A Clinical Evaluation of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population (SV JAPAN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01115933
First received: April 5, 2010
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease caused by de novo lesions.


Condition Intervention
Chronic Coronary Occlusion
Stent Thrombosis
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Device: AVJ-09-385 EECSS

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SPIRIT PRIME JAPAN (SV JAPAN)

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Major Adverse Cardiac Events (MACE): Composite of Any of the Following Adverse Events: Cardiac Death, Target Vessel Myocardial Infarction (TV-MI), Clinically Indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Device Success (Lesion Based Analysis, Only for XIENCE PRIME SV) [ Time Frame: The period during an in-hospital stay of less than or equal to 7 days post index procedure. ] [ Designated as safety issue: Yes ]
    Device success is achievement final in-stent residual diameter stenosis of < 50% (by QCA). If adjunct treatment devices other than protocol defined device is used for target lesion treatment, malfunction of the investigational device occurring during the index procedure, are not regarded as device success. Use of a bail-out stent is still regarded as device success unless a device malfunction has occured. If QCA %DS is not available, the data is not included in analyses.

  • Procedural Success(Subject Base Analysis) [ Time Frame: The period during an in-hospital stay of less than or equal to 7 days post index procedure. ] [ Designated as safety issue: Yes ]
    Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA) using the investigational device (AVJ-09-385), without the occurrence MACE during the hospital stay (up to 7 days if a subject still in the hospital). If QCA %DS is not available, the data is not included in analyses.

  • Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

    DEATH (Per ARC Circulation 2007; 115: 2344-2351)

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.


  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

    Definitions in SPIRIT III Study:

    Q wave MI: Development of new, pathological Q wave on the ECG

    Non-Q wave MI: Elevation of CK levels to  two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves

    Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351


  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.

  • Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. In the absence of any ischemic symptom, the following revascularization will be considered "clinically-indicated":

  • Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351

  • Target Vessel Revascularization (TVR, Per ARC Definition) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  • Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • All Coronary Revascularization [ Time Frame: 1 months ] [ Designated as safety issue: No ]
  • Composite Endpoint of Death/All MI [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (MACE) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    MACE is defined as a composite of cardiac death, target-vessel related myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization (CI-TLR).

  • Composite Endpoint of Cardiac Death/All MI/CI-TLR [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Death/All MI/All Revascularization [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Stent thrombosis is defined per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation. 2007 May 1;115(17):2344-51., 2007.

  • Stent Thrombosis (Per ARC Definition): Timing (Acute, Sub-acute, Late and Very Late) [ Time Frame: 1 months ] [ Designated as safety issue: Yes ]
    Acute stent thrombosis: 0 - 24 hours post stent implantation Subacute stent thrombosis: >24 hours . 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation

  • Stent Thrombosis (Per ARC Definition): Evidence (Definite, Probable and Possible) [ Time Frame: 1 months ] [ Designated as safety issue: Yes ]
  • Percent Diameter Stenosis (%DS), In-segment, In-stent, Proximal and Distal [ Time Frame: 8 months ] [ Designated as safety issue: No ]

    IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.

    PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement


  • Late Loss (LL), In-segment, In-stent, Proximal and Distal [ Time Frame: 8 months ] [ Designated as safety issue: No ]

    LATE LOSS (LL) calculated as MINIMUM LUMEN DIAMETER [MLD] post-procedure MINUS MLD at follow-up:

    In-segment Late Loss: in-segment MLD post-procedure - in segment MLD at follow-up In-stent Late Loss: in-stent MLD post-procedure - in-stent MLD at follow-up Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement) Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)


  • Angiographic Binary Restenosis (ABR), In-segment, In-stent, Proximal and Distal [ Time Frame: 8 months ] [ Designated as safety issue: No ]

    IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.

    PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement


  • Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • All Coronary Revascularization [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • All Coronary Revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • All Coronary Revascularization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • All Coronary Revascularization [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • All Coronary Revascularization [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • All Coronary Revascularization [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Composite Endpoint of Death/All MI [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Death/All MI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Death/All MI [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Death/All MI [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Death/All MI [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Death/All MI [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (MACE) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (MACE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (MACE) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (MACE) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (MACE) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (MACE) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death/All MI/CI-TLR [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death/All MI/CI-TLR [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death/All MI/CI-TLR [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death/All MI/CI-TLR [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death/All MI/CI-TLR [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac Death/All MI/CI-TLR [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Death/All MI/All Revascularization [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Composite endpoint of death, all MI and all revascularization will be presented as a percentage of participants

  • Composite Endpoint of Death/All MI/All Revascularization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Composite endpoint of death, all MI and all revascularization will be presented as a percentage of participants

  • Composite Endpoint of Death/All MI/All Revascularization [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Composite endpoint of death, all MI and all revascularization will be presented as a percentage of participants

  • Composite Endpoint of Death/All MI/All Revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Composite endpoint of death, all MI and all revascularization will be presented as a percentage of participants

  • Composite Endpoint of Death/All MI/All Revascularization [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Death/All MI/All Revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Composite endpoint of death, all MI and all revascularization will be presented as a percentage of participants

  • Stent Thrombosis (Per ARC Definition) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition): Timing (Acute, Sub-acute, Late and Very Late) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition): Timing (Acute, Sub-acute, Late and Very Late) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition): Timing (Acute, Sub-acute, Late and Very Late) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition): Timing (Acute, Sub-acute, Late and Very Late) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition): Timing (Acute, Sub-acute, Late and Very Late) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition): Timing (Acute, Sub-acute, Late and Very Late) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition): Evidence (Definite, Probable and Possible) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition): Evidence (Definite, Probable and Possible) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition): Evidence (Definite, Probable and Possible) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition): Evidence (Definite, Probable and Possible) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition): Evidence (Definite, Probable and Possible) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis (Per ARC Definition): Evidence (Definite, Probable and Possible) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 65
Study Start Date: April 2010
Estimated Study Completion Date: August 2016
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AVJ-09-385 SV EECSS
SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System
Device: AVJ-09-385 EECSS
Patients receiving AVJ-09-385 EECSS

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must be at least 20 years of age.
  2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
  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 to undergo all protocol-required follow-up procedures.
  6. 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 (one target and one non-target) de novo lesions each in a different epicardial vessel.
  2. Lesion(s) 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.
  3. Lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.25 mm and < 2.5 mm.
  4. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 22 mm.

Exclusion Criteria:

  1. Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB 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) < 40% (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 radiotherapy to the chest/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, warfarin).
  11. Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.
  12. Subject has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
  13. Elective surgery is planned within 6 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 white blood cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
  15. Subject has known renal insufficiency (examples being but not limited to serum creatinine level ≥ 2.0 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 5 French catheter insertion.
  20. Subject has other medical illness (e.g., cancer) 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*.

    • Whether a subject who met this criterion will be asked for pregnancy test will be decided per site standard. However, subject enrollment in the study is not allowed without pregnancy test result.

Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.

  1. Target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion) arterial or saphenous vein graft.
  2. Target lesion involving a bifurcation with a side branch ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed or side branch requiring protection guidewire, or side branch requiring dilatation.
  3. Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire.
  4. Another lesion requiring revascularization is located in the same epicardial vessel of the target lesion.
  5. Restenotic lesion.
  6. Aorto-ostial target lesion (within 3 mm of the aorta junction).
  7. Lesion in the left main trunk (both target and non-target).
  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 lesion.
  10. Heavy calcification proximal to or within the target lesion.
  11. Target vessel contains thrombus as indicated in the angiographic images.
  12. Target lesion has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treatment of the target vessel (e.g. rotablator, DCA, cutting balloon).
  13. Target vessel is previously treated* with any type of PCI (e.g. balloon angioplasty, stent, rotablator, DCA, cutting balloon) within 9 months of index procedure.
  14. Non-target vessel was previously treated with any type of PCI within 90 days of index procedure.
  15. Additional clinically significant lesion(s) in the target vessel or side branch for which PCI may be required within 90 days after the index procedure.

    • Target lesion must be separated ≥ 5 mm from a previously treated lesion (stenosis within 5 mm of previously treated lesion is regarded as "restenosis").
  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: NCT01115933

Locations
Japan
Kokura Memorial Hospital
Kita-kyushu, Fukuoka, Japan
Hokkaido Social Insurance Hospital Cardiovascular Center
Toyohira, Hokkaido, Japan
Teikyo University
Tokyo, Itabashi, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Saiseikai Yokohama City Eastern Hospital
Yokohama, Kanagawa, Japan
Kyoto University Hospital
Sakyo-ku, Kyoto, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Nagoya Daini Red Cross Hospital
Showa-ku, Nagoya, Japan
Kurashiki Central Hospital
Kurashiki, Okayama, Japan
Sakurabashi Watanabe Hospital
Kita-ku, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
Tokushima Red Cross Hospital
Komatsushima, Tokushima, Japan
Kumamoto Central Hospital
Kumamoto, Japan
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Takaaki Isshiki, MD Teikyo University Hospital
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01115933     History of Changes
Other Study ID Numbers: 09-385
Study First Received: April 5, 2010
Results First Received: August 6, 2013
Last Updated: November 14, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Abbott Vascular:
drug eluting stents
small vessel
Stents
Everolimus
Angioplasty

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Thrombosis
Vascular Diseases
Coronary Stenosis
Coronary Restenosis
Coronary Occlusion
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Embolism and Thrombosis
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014