meriT-V 1.1.0
Research type
Research Study
Full title
A Prospective, Active control Open label, Multicentre Randomized Clinical trial for comparison between BioMime Sirolimus Eluting Stent of Meril Life Sciences and Xience Family of Everolimus Eluting stent of Abbott Vascular Inc. to evaluate efficacy and safety in Coronary Artery Disease
IRAS ID
145688
Contact name
Dr.Ashish Indani
Contact email
Sponsor organisation
Meril Life Sciences
Eudract number
2013-005353-67
ISRCTN Number
ISRCTN06697555
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U1111-1154-3416 , The Universal Trial Number (UTN)
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
MeriT-V is a study that compares the safety & efficacy of two different different types of stent, the BioMime Sirolimus stent and the Xience Everolimus stent. The study will look at patients who are being treated for coronary artery disease and will undergo a Percutaneous Coronary Intervention (PCI) to widen/open up the arteries within the heart.
Patients will be randomized in 2:1 method to the study an patients will follow patients for a two year period in which they will attend a mixture of clinic visits and telephone follow ups. Nine months after the procedure patients will undergo a second coronary angiogram that will take place in the catheterisation Laboratory. Patients will also complete a quality of life questionnaire and their on going medication regime will be noted. These images will be used in addition to the images taken before and after their procedure to analyse and compare the efficacy and safety of each stent.
In order to be eligible for the study patients must be over 18 years old, clinical evidence of ischemia, two blockages (de-novo lesions) and the blockages must be treatable with one study stent.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
15/NW/0457
Date of REC Opinion
16 Jul 2015
REC opinion
Further Information Favourable Opinion