Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-03 @ 7:54 PM
Study NCT ID:
NCT01966159
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2013-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The EVOLVE China Clinical Trial
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
EVOLVE China: A Prospective, Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Atherosclerotic Lesion(s)
Status:
COMPLETED
Status Verified Date:
2023-11
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:
EVOLVE-CHINA
Brief Summary:
The purpose of this study is to assess the safety and effectiveness of the SYNERGY™ Coronary Stent System for 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)
Detailed Description:
The EVOLVE China clinical trial is designed to assess the safety and effectiveness of the SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) in native coronary arteries in China. The SYNERGY™ Stent System (Boston Scientific Corporation \[BSC Corporation\], Natick, Massachusetts, United States) is based on the well characterized Element™ stent platform and utilizes a bioabsorbable poly(DL-lactide-co-glycolide) (PLGA) polymer to deliver everolimus.
While SYNERGY is a new generation DES, the safety and effectiveness of the Element stent platform in combination with everolimus in the form of the PROMUS Element stent has been established in the PLATINUM Clinical Trial Program.The PROMUS Element Plus stent (control device) uses the same stent platform as PROMUS Element stent with a modified balloon component on the Stent Delivery System to improve overall system deliverability. In addition, the previous version of the SYNERGY stent, the SYNERGY First Human Use stent (SYNERGY FHU stent) has been investigated in the EVOLVE FHU trial which has completed its primary endpoint and demonstrated comparable safety and efficacy profile of SYNERGY FHU to PROMUS Element up to 1-year follow-up (28). SYNERGY has been approved by CE Mark.
While SYNERGY is a new generation DES, the safety and effectiveness of the Element stent platform in combination with everolimus in the form of the PROMUS Element stent has been established in the PLATINUM Clinical Trial Program.The PROMUS Element Plus stent (control device) uses the same stent platform as PROMUS Element stent with a modified balloon component on the Stent Delivery System to improve overall system deliverability. In addition, the previous version of the SYNERGY stent, the SYNERGY First Human Use stent (SYNERGY FHU stent) has been investigated in the EVOLVE FHU trial which has completed its primary endpoint and demonstrated comparable safety and efficacy profile of SYNERGY FHU to PROMUS Element up to 1-year follow-up (28). SYNERGY has been approved by CE Mark.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: