XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Abbott Medical Devices
- Enrollment
- 8053
- Locations
- 1
- Primary Endpoint
- Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Constortium).
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives of this study are
- To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and
- To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.
Detailed Description
Study Phase I is from index procedure to 1 year. This prospective, open-label, multi-center, observational, single-arm study is designed to evaluate XIENCE V EECSS safety and effectiveness in real world settings up to 1 year after implantation. The primary endpoint is the stent thrombosis (definite and probable) rate up to 1 year as ARC. The co-primary endpoint is the composite rate of cardiac death and any MI at 1 year. Up to 8,000 patients are planned to be consecutively enrolled at up to 275 sites in the U.S. Clinical follow-up will occur at 14, 30, 180 days and 1 year. All patients enrolled in the XIENCE V USA who have completed Study Phase I will be evaluated at 1 year to determine whether they are eligible to participate in one of the following cohorts in Study Phase II: XIENCE V USA Long Term Follow-up (LTF) Cohort, Harvard Clinical Research Institute (HCRI) DAPT Cohort, or Abbott Vascular (AV) DAPT Cohort.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient agrees to participate in this study by signing the Institutional Review Board approved informed consent form.
Exclusion Criteria
- •The inability to obtain an informed consent.
- •Age limit is determined by investigator.
- •There are no angiographic inclusion or exclusion criteria for this study.
Outcomes
Primary Outcomes
Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Constortium).
Time Frame: up to 1 year
ARC Defines Stent Thrombosis in the following way: Definite Stent Thrombosis: Angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region AND at least ONE of the following, additional criteria: Acute ischemic symptoms Ischemic ECG changes Elevated cardiac biomarkers Probable Stent Thrombosis: Any unexplained death within 30 days of stent implantation or any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause Possible Stent Thrombosis Any unexplained death beyond 30 days For further information on ARC definitions, please refer to the following website: http://circ.ahajournals.org/content/115/17/2344.full#sec-1
Composite Rate of Cardiac Death and Any Myocardial Infarction (MI)
Time Frame: 1 year
MI= ARC (Academic Research Constortium) defined
Secondary Outcomes
- Clinical Device Success(acute: post index procedure until hospital discharge)
- Procedural Success(acute: post index procedure until hospital discharge)
- Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)(at 180 days)
- Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)(at 1 year)
- Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])(at 1 year)
- Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)(at 1 year)
- Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)(at 1 year)
- Any MI (Q-wave and Non Q-wave)(at 1 year)
- Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)(at 1 year)
- Major Bleeding Complications(at 1 year)
- Dual Antiplatelet Medication Usage(at 1 year)
- Dual Antiplatelet Therapy Non-compliance Through 1 Year(1 year)
- Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)(at 1 year)
- Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)(at 1 year)
- SAQ (Seattle Angina Questionaire)(1 year)