SPIRIT Small Vessel Registry (SPIRIT SV)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00783796
First received: October 30, 2008
Last updated: November 19, 2013
Last verified: October 2013
  Purpose

To evaluate the safety and effectiveness of the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in improving coronary luminal diameter in subjects with ischemic heart disease due to a maximum of two de novo native coronary artery lesions in small vessels, each in a different epicardial vessel.


Condition Intervention Phase
Coronary Artery Disease
Atherosclerosis
Myocardial Ischemia
Device: 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Spirit Small Vessel Registry (SPIRIT SV)

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR). [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.


Secondary Outcome Measures:
  • Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap) [ Time Frame: From start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    Successful delivery and deployment of the first study stent intended to be implanted at the intended target lesion (or intended first and second investigational stents for overlapping stents), successful withdrawal of the stent delivery system, and attainment of final residual stenosis of <50%.

  • Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions) [ Time Frame: From the start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    Achievement of a final in-stent diameter stenosis of <50% using the study device, without the occurence of cardiac death, target vessel myocardial infarction per protocol definition, or repeat revascularization of the target lesion during the hospital stay up to 7 days.

  • In-Stent Late Loss [ Time Frame: 240 days ] [ Designated as safety issue: No ]
    In-stent minimum lumen diameter (MLD) post-procedure minus in-stent MLD at angiographic follow-up.

  • In-segment Late Loss (LL) [ Time Frame: 240 Days ] [ Designated as safety issue: No ]
    In-segment minimum lumen diameter (MLD) post-procedure minus in-segment MLD at angiographic follow-up.

  • Proximal Late Loss [ Time Frame: 240 days ] [ Designated as safety issue: No ]
    Proximal minimum lumen diameter (MLD) post-procedure minus proximal MLD at angiographic follow-up (proximal defined as 5 mm of healthy tissue proximal to stent placement).

  • Distal Late Loss [ Time Frame: 240 days ] [ Designated as safety issue: No ]
    Distal minimum lumen diameter (MLD) post-procedure minus distal MLD at angiographic follow-up (distal defined as 5 mm of healthy tissue distal to stent placement).

  • In-stent % Diameter Stenosis [ Time Frame: 240 days ] [ Designated as safety issue: No ]
    Value calculated as 100*(1-MLD/RVD) where MLD is in-stent minimum lumen diameter and RVD is in-stent reference vessel diameter.

  • In-segment % Diameter Stenosis [ Time Frame: 240 days ] [ Designated as safety issue: No ]
    Value calculated as 100*(1-MLD/RVD) where MLD is in-segment minimum lumen diameter and RVD is in-segment reference vessel diameter.

  • Proximal % Diameter Stenosis [ Time Frame: 240 days ] [ Designated as safety issue: No ]
    Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue proximal to stent placement.

  • Distal % Diameter Stenosis [ Time Frame: 240 days ] [ Designated as safety issue: No ]
    Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue distal to stent placement.

  • In-stent Angiographic Binary Restenosis (ABR) Rate [ Time Frame: 240 days ] [ Designated as safety issue: No ]
    Percentage of patients with target lesions with ≥ 50% in-stent % diameter stenosis at angiographic follow-up.

  • In-segment Angiographic Binary Restenosis (ABR) Rate [ Time Frame: 240 days ] [ Designated as safety issue: No ]
    Percentage of patients with target lesions with ≥ 50% in-segment % diameter stenosis at angiographic follow-up.

  • Proximal Angiographic Binary Restenosis (ABR) Rate [ Time Frame: 240 days ] [ Designated as safety issue: No ]
    Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue proximal to stent placement at angiographic follow-up.

  • Distal Angiographic Binary Restenosis (ABR) Rate [ Time Frame: 240 days ] [ Designated as safety issue: No ]
    Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue distal to stent placement at angiographic follow-up.

  • All Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    All death, including death from cardiac, vascular, and non-cardiovascular causes.

  • All Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    All death, including death from cardiac, vascular, and non-cardiovascular causes.

  • All Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    All death, including death from cardiac, vascular, and non-cardiovascular causes.

  • All Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    All death, including death from cardiac, vascular, and non-cardiovascular causes.

  • All Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    All death, including death from cardiac, vascular, and non-cardiovascular causes.

  • All Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    All death, including death from cardiac, vascular, and non-cardiovascular causes.

  • All Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    All death, including death from cardiac, vascular, and non-cardiovascular causes.

  • Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

  • Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

  • Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

  • Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

  • Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

  • Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

  • Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

  • Stent Thrombosis (ARC Defined) [ Time Frame: 0 to 1 day (Acute) ] [ Designated as safety issue: Yes ]
    ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

  • Stent Thrombosis (ARC Defined) [ Time Frame: greater than 1 day to 30 days (Subacute) ] [ Designated as safety issue: Yes ]
    ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

  • Stent Thrombosis (ARC Defined) [ Time Frame: 31 days - 393 days (Late) ] [ Designated as safety issue: Yes ]
    Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

  • Stent Thrombosis (ARC Defined) [ Time Frame: >1 year (Very late) ] [ Designated as safety issue: Yes ]
    Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

  • Stent Thrombosis (Protocol Defined) [ Time Frame: 0 to 1 day (Acute) ] [ Designated as safety issue: Yes ]
    Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

  • Stent Thrombosis (Protocol Defined) [ Time Frame: > 1 day to 30 days (Subacute) ] [ Designated as safety issue: Yes ]
    Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

  • Stent Thrombosis (Protocol Defined) [ Time Frame: 31 days to 393 days (Late) ] [ Designated as safety issue: Yes ]
    Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

  • Stent Thrombosis (Protocol Defined) [ Time Frame: 0-758 days ] [ Designated as safety issue: Yes ]
    Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

  • All Death/ All MI/All Coronary Revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

  • All Death/ All MI/All Coronary Revascularization [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

  • All Death/ All MI/All Coronary Revascularization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

  • All Death/ All MI/All Coronary Revascularization [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

  • All Death/ All MI/All Coronary Revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

  • All Death/ All MI/All Coronary Revascularization [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

  • All Death/ All MI/All Coronary Revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

  • Cardiac Death/ All MI /CI-TLR [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

  • Cardiac Death/ All MI /CI-TLR [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

  • Cardiac Death/ All MI /CI-TLR [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

  • Cardiac Death/ All MI /CI-TLR [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

  • Cardiac Death/ All MI /CI-TLR [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

  • Cardiac Death/ All MI /CI-TLR [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

  • Cardiac Death/ All MI /CI-TLR [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

  • Cardiac Death/MI [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

  • Cardiac Death/MI [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

  • Cardiac Death/MI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

  • Cardiac Death/MI [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

  • Cardiac Death/MI [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

  • Cardiac Death/MI [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

  • Cardiac Death/MI [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

  • All Coronary Revascularization (TVR and Non-TVR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.

  • All Coronary Revascularization (TVR and Non-TVR) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.

  • All Coronary Revascularization (TVR and Non-TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.

  • All Coronary Revascularization (TVR and Non-TVR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.

  • All Coronary Revascularization (TVR and Non-TVR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.

  • All Coronary Revascularization (TVR and Non-TVR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.

  • All Coronary Revascularization (TVR and Non-TVR) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.

  • All TVR (CI and Non-CI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

  • All TVR (CI and Non-CI) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

  • All TVR (CI and Non-CI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

  • All TVR (CI and Non-CI) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

  • All TVR (CI and Non-CI) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

  • All TVR (CI and Non-CI) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

  • All TVR (CI and Non-CI) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

  • All TLR (CI and Non-CI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.

  • All TLR (CI and Non-CI) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.

  • All TLR (CI and Non-CI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.

  • All TLR (CI and Non-CI) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.

  • All TLR (CI and Non-CI) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.

  • All TLR (CI and Non-CI) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.

  • All TLR (CI and Non-CI) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.

  • Clinically Indicated Target Vessel Revascularization (TVR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

  • Clinically Indicated Target Vessel Revascularization [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

  • Clinically Indicated Target Vessel Revascularization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

  • Clinically Indicated Target Vessel Revascularization [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

  • Clinically Indicated Target Vessel Revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

  • Clinically Indicated Target Vessel Revascularization [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

  • Clinically Indicated Target Vessel Revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

  • Clinically Indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

  • Clinically Indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

  • Clinically Indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

  • Clinically Indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

  • Clinically Indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

  • Clinically Indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

  • Clinically Indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

  • Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

  • Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

  • Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

  • Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

  • Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

  • Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

  • Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

  • Target Vessel MI - Q-wave and Non Q-wave (Per ARC) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

  • Target Vessel MI - Q-wave and Non Q-wave (Per ARC) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

  • Target Vessel MI - Q-wave and Non Q-wave (Per ARC) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

  • Target Vessel MI - Q-wave and Non Q-wave (Per ARC) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

  • Target Vessel MI - Q-wave and Non Q-wave (Per ARC) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

  • Target Vessel MI - Q-wave and Non Q-wave (Per ARC) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

  • Target Vessel MI - Q-wave and Non Q-wave (Per ARC) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

  • Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

  • Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

  • Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

  • Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

  • Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

  • Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

  • Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).


Enrollment: 150
Study Start Date: October 2008
Estimated Study Completion Date: October 2014
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2.25mm XIENCE V®
Patients receiving the 2.25 mm XIENCE V® stent
Device: 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System
Treatment of a maximum of two de novo native coronary artery lesions in small vessels.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria

  1. Subject must be at least 18 years of age.
  2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure.
  3. Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
  4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  5. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.

Angiographic Inclusion Criteria

  1. One target or two (two target or one target and one non-target) de novo lesion(s), each in a different epicardial vessel.
  2. If there are two target lesions or one target and one non-target lesion, both lesions must satisfy the angiographic eligibility criteria.
  3. The target lesion(s) or non-target lesion must be located in a major artery or branch with a visually estimated diameter stenosis of ≥50% and < 100% with a TIMI flow of ≥1.
  4. The target lesion(s) or non-target lesion must be located in a native coronary artery with a reference vessel diameter by visual estimation of: Target Lesion: ≥ 2.25 mm to < 2.5 mm for treatment by the 2.25 mm XIENCE V® EECS.

    Non-target Lesion: ≥2.5 mm to ≤4.25 mm for treatment by the commercial XIENCE V® EECS.

  5. The target lesion(s) or non-target lesion must be located in a native coronary artery with a lesion length by visual estimation of ≤28 mm.

General Exclusion Criteria

  1. Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥2 times the upper limit of normal) and CK and CK-MB levels have not returned to within normal limits at the time of procedure.
  2. The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
  3. Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.
  4. Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
  5. Subject has received coronary brachytherapy in any epicardial vessel.
  6. Subject has received any organ transplant or is on a waiting list for any organ transplant.
  7. Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
  8. Subject is receiving or scheduled to receive planned radiation therapy to the chest or mediastinum.
  9. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).
  10. Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
  11. Subjects who will require Low Molecular Weight Heparin (LMWH) post-procedure.
  12. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoropolymers or contrast sensitivity that cannot be adequately pre-medicated.
  13. Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel.
  14. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
  15. Subject has known renal insufficiency (eg, serum creatinine level ≥ 2.5 mg/dL, or on dialysis).
  16. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  17. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
  18. Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.
  19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
  20. Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
  21. Subject is currently participating in another clinical study that has not yet completed its primary endpoint.
  22. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

Angiographic Exclusion Criteria

  1. Target lesion(s) or non-target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.
  2. Target lesion(s) or non-target lesion involving a bifurcation with a side branch ≥2 mm in diameter and/or ostial lesion > 40% stenosed by visual estimation or side branch requiring protection guide wire, or side branch requiring dilatation.
  3. Total occlusion (TIMI flow 0), prior to crossing with the wire.
  4. Another lesion requiring revascularization is located in the same epicardial vessel of either the target or non-target lesion.
  5. Restenotic lesion.
  6. Aorto-ostial lesion (within 3 mm of the aorta junction).
  7. Left main location.
  8. Lesion located within 2 mm of the origin of the LAD or LCX.
  9. Extreme angulation (≥90°) or excessive tortuosity (≥ two 45° angles) proximal to or within the target or non-target lesion.
  10. Heavy calcification proximal to or within the target or non-target lesion(s).
  11. Target or non-target vessel contains thrombus as indicated in the angiographic images.
  12. Target lesion(s) or non-target lesion have a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treating the target and non-target vessel(s) (e.g. atherectomy, cutting balloon).
  13. Target or non-target vessel(s) have previously been treated with percutaneous intervention (e.g. balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure.
  14. A vessel not intended to be treated with a 2.25 mm XIENCE V® EECS or commercial sizes of XIENCE V® EECS that was previously treated with any type of PCI < 90 days prior to the index procedure.
  15. Additional clinically significant lesion(s) (e.g., %DS≥ 50%) is present in any vessel or side branch for which PCI may be required < 90 days after the index procedure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783796

  Show 34 Study Locations
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Marco A. Costa, MD, PhD Case Western University Hospital, Cleveland, OH
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00783796     History of Changes
Other Study ID Numbers: 08-383
Study First Received: October 30, 2008
Results First Received: November 29, 2011
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
Coronary artery disease
Atherosclerosis
Myocardial ischemia

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014