XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Heart Disease
- Sponsor
- Abbott Medical Devices
- Enrollment
- 312
- Locations
- 33
- Primary Endpoint
- Number of Participants With Stent Thrombosis: Subacute
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV in real world practice in Japanese hospitals.
Detailed Description
Based on Good Post-marketing Study Practice (GPSP) regulation, general patient population with ischemic heart disease who are eligible for treatment with XIENCE PRIME SV Everolimus Eluting Stent will be registered, with no particular inclusion/exclusion criteria, and may be eligible for angiographic follow-up at eight months and clinical follow-up at one year.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants With Stent Thrombosis: Subacute
Time Frame: >24 hours to 30 days post stent implantation
Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Subacute stent thrombosis : \>24 hours to 30 days after stent implantation
Number of Participants With Stent Thrombosis: Acute
Time Frame: 0-24 hours post stent implantation
Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timing: Acute stent thrombosis: 0 to 24 hours after stent implantation
Number of Participants With Stent Thrombosis: Late
Time Frame: 30 days to 1 year post stent implantation
Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Late stent thrombosis : \>30 days to 1 year after stent implantation
Secondary Outcomes
- Number of Participants With Stent Thrombosis: Very Late(>1 year post stent implantation)
- Number of Participants With Target Lesion Revascularization(0-5 years)
- Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)(0-5 years)
- Number of Participants With Target Vessel Failure(0 to 5 years)
- Number of Participants With Cardiac Death or Target Vessel-MI(0 to 1 year)
- Percent Diameter Stenosis (%DS)(8 months)
- Success Rate: Percentage of Devices With Implant Success(< or = 1 day)
- Number of Participants With All Revascularization(0 to 5 years)
- Success Rate: Percentage of Lesions With Procedural Success(< or = 1 day)
- Net Gain: In-stent, In-segment(Post-Procedure (on day 0))
- Success Rate: XIENCE PRIME Implant Success by Patient(< or = 1 day)
- Number of Death(0-５ years)
- Number of Participants With Major Adverse Cardiac Events (MACE)(0 to 5 years)
- Number of Participants With Cardiac Death or Target-Vessel MI(0 to 8 months)
- Number of Participants With Cardiac Death or Target Vessel MI(0 to 5 years)
- Number of Participants With Myocardial Infarction(0-5 years)
- Acute Gain: In-stent,In-segment(Pre procedure to post procedure (on day 0))
- Number of Participants With Non-target Vessel Revascularization (Non-TVR)(0 to 5 years)
- Number of Participants With Hemorrhage(0 to 5 years)
- Number of Participants With Target Lesion Failure(0 to 5 years)
- Late Loss(LL): In-stent,In-segment,Proximal, and Distal(8 months)
- Number of Participants With All Death/All MI/All Revascularization(0 to 5 years)
- Number of Participants With Death or MI(0 to 5 years)
- Number of Participants With Cardiac Death or MI(0 to 5 years)