Cardiovascular Diseases
Conditions
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.
Interventions
DEVICESYNERGYTM Stent System
no intervention design in the study
Sponsors
Boston Scientific Corporation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • 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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE rate | 12 months | endpoints will be assessed post stent implant |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJunbo Ge
Fudan University
Outcome results
None listed