Trials / Active Not Recruiting
Active Not RecruitingNCT03736226
A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China
A Post-Approval, Single-Arm Study of the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System in China
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,000 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SYNERGYTM Stent System | no intervention design in the study |
Timeline
- Start date
- 2019-07-30
- Primary completion
- 2024-08-01
- Completion
- 2028-03-31
- First posted
- 2018-11-09
- Last updated
- 2026-03-24
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03736226. Inclusion in this directory is not an endorsement.