SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
This study has been completed.
Sponsor:
Abbott Vascular
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01171820
First received: April 1, 2010
Last updated: October 1, 2010
Last verified: October 2010
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Purpose
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions in patients (Diabetic sub-study).
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Disease Coronary Artery Disease Coronary Restenosis |
Device: TAXUS® Liberté™ Device: XIENCE V® EECSS |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions |
Resource links provided by NLM:
Further study details as provided by Abbott Vascular:
Primary Outcome Measures:
- In-stent Late Loss(LL) [ Time Frame: 270 days ] [ Designated as safety issue: No ]In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up
Secondary Outcome Measures:
- Clinical Device Success [ Time Frame: Acute: At time of index procedure ] [ Designated as safety issue: No ]Successful delivery and deployment of the study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stent) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable), without use of a device outside the assigned treatment strategy.
- Clinical Procedure Success [ Time Frame: Acute: At time of index procedure ] [ Designated as safety issue: Yes ]Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of cardiac death, MI attributed to the target vessel and/or CI-TLR during the hospital stay with a maximum of first seven days post index procedure. In multiple lesion setting each lesion must meet clinical procedure success.
- In-segment Late Loss [ Time Frame: 270 days ] [ Designated as safety issue: No ]In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up
- Proximal Late Loss [ Time Frame: 270 day ] [ Designated as safety issue: No ]Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up
- Distal Late Loss [ Time Frame: 270 days ] [ Designated as safety issue: No ]Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up
- In-stent Angiographic Binary Restenosis Rate [ Time Frame: 270 days ] [ Designated as safety issue: No ]Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per Quantitative Coronary Angiogram.
- In-segment Angiographic Binary Restenosis Rate [ Time Frame: 270 days ] [ Designated as safety issue: No ]Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per Quantitative Coronary Angiogram.
- In-stent Percent Diameter Stenosis [ Time Frame: 270 days ] [ Designated as safety issue: No ]
This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.
This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiogram.
- In-segment Percent Diameter Stenosis [ Time Frame: 270 days ] [ Designated as safety issue: No ]
This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.
This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiogram.
- Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]A thrombosis is blood clot that forms on the stent. This outcome measures the percentage of participants found to have this condition.
- Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]A thrombosis is blood clot that forms on the stent
- Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]A thrombosis is blood clot that forms on the stent
- Adjudicated Revascularizations (TLR/TVR/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Adjudicated Revascularizations (TLR/TVR/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
- Adjudicated Revascularizations (TLR/TVR/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Adjudicated Composite Rate of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Adjudicated Composite Rate of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
- Adjudicated Composite Rate of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Adjudicated Composite Rate of All Death, MI and Target Vessel Revascularization (TVR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Adjudicated Composite Rate of All Death, MI and Target Vessel Revascularization (TVR) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
- Adjudicated Composite Rate of All Death, MI and Target Vessel Revascularization (TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Adjudicated Composite Rate of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Adjudicated Composite Rate of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
- Adjudicated Composite Rate of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 324 |
| Study Start Date: | November 2006 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: TAXUS® Liberté™ |
Device: TAXUS® Liberté™
Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes
|
| Active Comparator: XIENCE V® EECSS |
Device: XIENCE V® EECSS
Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes
|
Detailed Description:
The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic sub-study and the Registry.
The SPIRIT V Diabetic sub-study is a prospective, randomized, active-controlled, single blind, parallel two-arm multi-center study comparing the XIENCE V® EECSS to the TAXUS® Liberté™ in the treatment of diabetic patients with coronary artery lesions who will fulfill the eligibility criteria. Approximately 300 patients will be randomized (2:1) against the TAXUS® Liberté™ coronary stent system. These patients will be recruited in up to 40 selected sites.
The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.
The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.
Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT V Diabetic study after 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- at least 18 years
- able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
- diagnosed with diabetes, as documented by medical history.
- evidence of myocardial ischemia
- acceptable candidate for CABG surgery
- agree to undergo all CIP-required follow-up examinations
- artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned stents
- maximum of one, de novo, target lesion per native major epicardial vessel or side branch
- target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
- target lesion ≤ 28 mm in length by visual estimate
- target lesion must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% and a TIMI flow > 1
Exclusion Criteria:
- known diagnosis of AMI within 72 hours preceding the index procedure
- current unstable arrhythmias
- LVEF < 30%
- received a heart or any other organ transplant or is on a waiting list for any organ transplant
- receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
- receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease
- known hypersensitivity or contraindication to specific agents
- elective surgery is planned within the first 9 months after the procedure that will require discontinuing either aspirin or clopidogrel
- platelet count limits, WBC limits or documented or suspected liver disease
- renal insufficiency
- history of bleeding diathesis or coagulopathy or will refuse blood transfusions
- CVA or TIA within the past 6 months
- significant GI or urinary bleed within the past 6 months
- history of other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse that may cause non-compliance with the CIP, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)
Target lesion meets any of the following criteria:
- In-stent restenotic
- aorto-ostial location (within 3 mm)
- left main location
- located within 2 mm of the origin of the LAD or LCX
- located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation)
- lesion involving a side branch ≥ 2.5 mm in diameter
- lesion involving a side branch with > 50% stenosis by visual estimation Lesion involving a side branch requiring predilatation
- located in a major epicardial vessel that has been previously treated with brachytherapy
- located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy), < 9 months prior to the index procedure
- total occlusion (TIMI flow 0), prior to wire crossing
- excessive tortuosity proximal to or within the lesion
- extreme angulation (≥ 90%) proximal to or within the lesion
- heavy calcification
The target vessel contains visible thrombus
Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. brachytherapy)
Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171820
Locations
| Austria | |
| Salzburger Landeskliniken | |
| Salzburg, Austria | |
| France | |
| C.H.U. - Hopital Michallon | |
| Grenoble, France | |
| CHU Lille - Hôpital Cardiologique | |
| Lille, France | |
| Germany | |
| Herzzentrum | |
| Bernau, Germany | |
| Universitätsklinikum | |
| Heidelberg, Germany | |
| Lukas Krankenhaus Neuss | |
| Neuss, Germany | |
| Herzzentrum Siegburg GmbH | |
| Siegburg, Germany | |
| Israel | |
| Sheba Medical Center | |
| Ramat Gan, Israel | |
| Italy | |
| Azienda Ospedaliera Riuniti | |
| Bergamo, Italy | |
| Ospedale Civile | |
| Mirano, Italy | |
| Azienda Ospedaliera di Padova | |
| Padova, Italy | |
| IRCCS Policlinico San Matteo | |
| Pavia, Italy | |
| Azienda Ospedaliera S. Gdi Dio Salerno | |
| Salerno, Italy | |
| Malaysia | |
| Institute Jantung Negara | |
| Kuala Lumpur, Malaysia | |
| Netherlands | |
| Medisch Centrum Alkmaar | |
| Alkmaar, Netherlands | |
| Maasstad Ziekenhuis | |
| Rotterdam, Netherlands | |
| Poland | |
| Medical University of Bydgoszcz | |
| Bydgoszcz, Poland | |
| Spain | |
| General De Alicante | |
| Alicante, Spain | |
| Hospital Belvigte de Barcelona | |
| Barcelona, Spain | |
| Hospital Santa Creu I Sant Pau | |
| Barcelona, Spain | |
| Hospital Puerta de Hierro | |
| Madrid, Spain | |
| Clinico San Carlos | |
| Madrid, Spain | |
| La Paz | |
| Madrid, Spain | |
| Hospital Virgen de la Arrixaca | |
| Murcia, Spain | |
| Hospital General de Valencia | |
| Valencia, Spain | |
| Thailand | |
| King Chulalongkorn Memorial Hospital | |
| Bangkok, Thailand | |
| United Kingdom | |
| King's College Hospital | |
| London, United Kingdom | |
| Wessex Cardiac Unit | |
| Southampton, United Kingdom, SO16 6YD | |
Sponsors and Collaborators
Abbott Vascular
Investigators
| Principal Investigator: | Eberhard Grube, MD | International Heart Center Rhein-Ruhr, Essen, Germany |
| Principal Investigator: | Upendra Kaul, MD | Fortis Hospital, New Delhi, India |
More Information
Additional Information:
No publications provided
| Responsible Party: | Ellen Travis, Abbott Vascular |
| ClinicalTrials.gov Identifier: | NCT01171820 History of Changes |
| Other Study ID Numbers: | 05-369 Diabetic Sub-study |
| Study First Received: | April 1, 2010 |
| Results First Received: | August 31, 2010 |
| Last Updated: | October 1, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Abbott Vascular:
|
drug eluting stents stents Angioplasty coronary artery disease total coronary occlusion |
coronary artery restenosis stent thrombosis vascular disease myocardial ischemia coronary artery stenosis |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Coronary Restenosis Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Coronary Stenosis Everolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013