A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China
- Conditions
- Cardiovascular Diseases
- Registration Number
- NCT03736226
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
A prospective, observational, single-arm, open-label, multicenter, post-approval study. To compile real-world clinical outcomes data for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGYTM Stent System) in real-world clinical practice in China.
- Detailed Description
This prospective, open-label, multi-center study is designed to provide post-market surveillance information on the SYNERGY Stent System. The study will evaluate clinical outcomes of subjects receiving the SYNERGY™ stents over 5 years in a real world setting according to post approval requirements by China government.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2000
-
• Subject must be at least 18 years of age
- Subject understands and provides written informed consent
- Subject who is clinically indicated and will have an attempt of at least one SYNERGYTM stent OR Subject who is clinically indicated and was implanted with at least one SYNERGYTM stent
- Subject is willing to comply with all protocol-required follow-up evaluation
- Exclusion criteria are not required in this study which is an "all comers" study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MACE rate 12 months endpoints will be assessed post stent implant
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
Zhongshan Hospital Fudan University🇨🇳Shanghai, Shanghai, China