EVOLVE 48 (S2356) SYNERGYTM Stent System
Research type
Research Study
Full title
A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of the SYNERGYTM 48 mm Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGYTM 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
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
The study is an observation of the SYNERGY Stent System and coronary artery disease for a period of approximately 2 years after the initial implant of the device.
Coronary artery disease is a narrowing of one or more blood vessels (coronary arteries) that supply blood and oxygen to the heart. Coronary stenting is a commonly used procedure to treat coronary artery disease. Stents have been used for many years and are an effective treatment for coronary artery disease. Some stents, called drug-eluting stents, are coated with a drug which improves the performance of the stent by reducing the risk of artery re-narrowing. The SYNERGY Stent System, manufactured by Boston Scientific (BSC), is made of metal and coated with the drug everolimus. There is a coating (polymer) on the metal that is used to carry the drug.
The purpose of this study is to collect data on the SYNERGY 48 mm Stent System. The SYNERGY 48 mm Stent System is approved for commercial use in Europe and New Zealand.
Patients diagnosed with coronary artery disease will be invited to participate in this study.The number of subjects expected to participate in the study will be 100 at up to 20 study centres in the United States, Europe (Germany, Latvia and 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).
After the patient have signed the Informed Consent Form, the study doctor will confirm that the patient meet the eligibility criteria and will collect demographic information such as your age and gender. Patients will monitored closely during and after the coronary stenting procedure, and until they are discharged from the hospital. This monitoring is the standard of care for anyone receiving a stent.
After hospital discharge patients will be contacted by their study doctor or the study team by telephone or office visit at approximately 30 days, 6 months, 12 months and 2 years. During all follow-up contacts, their medical status will be evaluated.REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/0082
Date of REC Opinion
30 Jan 2018
REC opinion
Unfavourable Opinion