XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Angioplasty
- Sponsor
- Abbott Medical Devices
- Enrollment
- 2605
- Locations
- 1
- Primary Endpoint
- Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a prospective, observational, single-arm, open-label, multicenter, postapproval registry study in China. The purpose of this study is to:
- Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort of real-world patients receiving the XIENCE V EECSS during commercial use
- Evaluate patient compliance to dual antiplatelet therapy (DAPT)
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee-approved informed consent form (ICF).
- •Only XIENCE V stent(s) is/are implanted into the coronary vasculature during the index procedure.
Exclusion Criteria
- •The inability to obtain a signed ICF
Outcomes
Primary Outcomes
Number of Participants With Incidence of the Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
Time Frame: 0 to 1867 days
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Myocardial Infarction (MI) - 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.
Secondary Outcomes
- Number of Participants With Target Lesion Failure (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)(0 to 1867 days)
- Number of Participants With Composite Rate of All Death, Any MI, and Any Repeat Revascularization(0 to 1867 days)
- Number of Participants With Target Lesion Failure (TLF) (Composite Rate of Cardiac Death, TV-MI and Ischemia-driven TLR)(0 to 407 days)
- Number of Participants With Major Bleeding Complications (According to GUSTO Classification)(0 to 1867 days)
- Number of Participants With Ischemia-driven Target Vessel Failure (ID-TVF) (Composite Rate of Cardiac Death, All MI and Target Vessel Revascularization (TVR))(0 to 1867 days)
- Number of Participants Experiencing Death(0 to 1867 days)
- Number of Participants With Revascularization(0 to 1867 days)
- Number of Participants With All Target Lesions Revascularization(0 to 1137 days)
- Number of Participants With All Target Vessel Revascularization(0 to 1867 days)
- Number of Participants With Stent Thrombosis(0 to 1867 days)
- Number of Participants With Composite Rate of Cardiac Death, MI Attributed to the Target Vessel (TV-MI), and All Target Lesion Revascularization (TLR)(0 to 1867 days)
- Number of Participants With Any MI(0 to 1867 days)
- Number of Participants With Composite Rate of All Death and Any MI(0 to 1867 days)
- Number of Participants With All Target Lesion Revascularization(0 to 1867 days)
- Number of Participants Compliance With Dual Anti-platelet Therapy (DAPT)(5 years)