Apposition V
Research type
Research Study
Full title
STENTYS Coronary Stent System Clinical Trial in Subjects with ST Elevation Myocardial Infarction
IRAS ID
134820
Contact name
Andreas Baumbach
Contact email
Sponsor organisation
Stentys Inc.
Clinicaltrials.gov Identifier
Research summary
This is a prospective, multi-center, randomized clinical trial that will include up to 880 subjects in up to 60 sites worldwide. The study will include subjects who present with an acute myocardial infarction (STEMI) with a de novo stenotic lesion in the coronary artery and who will undergo primary revascularization as treatment.
The study objective is to evaluate the safety and effectiveness of the STENTYS Coronary Stent System as compared to the Multi-Link bare-metal stent platform (Abbott Vascular Inc.), measuring the target vessel failure and acute stent malapposition. The randomization schedule is 2:1 (Stentys stent : MultiLink stent).
There is a sub-study in a number of sites, having the first 212 enrolled subjects undergoing IVUS during the index procedure, 105 of the 212 subjects will undergo IVUS and angiography at 12 months and 60 subjects of the sub-group will undergo OCT during index procedure and at 12 months.
All patients meeting all selection criteria can be included. First subject has been enrolled in the Netherlands on 15-May-2013 and the enrolment phase is expected to last 18 months.
Subjects will be followed through 12 months with assessments at 30 days, 6 months, 9 months and 12 months, and annually through 3 years follow-up. The study will be considered finished when all subjects have completed the 3 year follow-up.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/0048
Date of REC Opinion
24 Apr 2014
REC opinion
Further Information Favourable Opinion