Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-02-21 @ 6:24 AM
Study NCT ID:
NCT02499692
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2015-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SYNERGY China: Assess SYNERGY Stent in China
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
SYNERGY China: A Prospective, Multicenter Trial to Assess the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites across China, the primary endpoint is Technical success.
Detailed Description:
The study is To evaluate clinical and peri-procedural angiographic outcomes for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: