NCT01966159

The EVOLVE China Clinical Trial

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 412 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	SYNERGY Investigational Device	percutaneous coronary intervention
DEVICE	PE Plus Investigational Device	percutaneous coronary intervention

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-07-01
• Completion: 2020-12-01
• First posted: 2013-10-21
• Last updated: 2023-11-15
• Results posted: 2016-02-18

Locations

14 sites across 1 country: China