EVOLVE 48 (S2356) SYNERGY Stent System
Research type
Research Study
Full title
A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of the SYNERGY 48 mm Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Subjects with Atherosclerotic Lesion(s)
IRAS ID
239587
Contact name
Azfar Zaman
Contact email
Sponsor organisation
Boston Scientific Corporation
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
The SYNERGY 48 mm Stent System is CE Marked and approved for use in the United Kingdom and through-out Europe and New Zealand.
In the UK the purpose of this study is to collect EU post-market safety and performance data for the current CE Marked 48 mm device. In addition, the data obtained from the UK will be combined with data obtained from the other participating countries and provided to FDA for product approval in the United States.
The SYNERGY stent is already in use in the United Kingdom and the potential patients would be receiving the 48 mm size under recommendation of their Doctor as per standard of care. This study will be an obser-vation of patients for 2 years following stent placement
After stent placement and hospital discharge patients will be contacted for data collection, by their study doctor or the study team by telephone at 30 days, 6 months, 12 months and 2 years. During all follow-up contacts, their medical status will be evaluated.Patients will only be required to consent for the 2 years of follow-up after stent placement. The device and the procedure by which it is implanted are not considered part of the study. That will be explained to the patients per standard of care by their doctors.
The number of subjects expected to participate in the study is 100 at up to 20 sites in the United States, Europe (Germany, Latvia, the United Kingdom) and New Zealand. In the United Kingdom, the study is expected to take place in 3 sites (England, Scotland and Northern Ireland).REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/0342
Date of REC Opinion
9 May 2018
REC opinion
Further Information Favourable Opinion