Coronary Artery Disease Clinical Trial
Official title:
A Prospective, Active Control Open Label, Multicentre Randomized Clinical Trial for Comparison Between BioMime Sirolimus Eluting Stent of Meril Life Sciences and Xience Everolimus Eluting Stent of Abbott Vascular Inc. to Evaluate Efficacy and Safety in Coronary Artery Disease.
meriT-V is a Prospective,active control open lable clinical trial to compare safety & efficacy of BioMime Sirolimus stent Vs. Xience family of Everolimus stent by random assignment for treatment of coronary artery disease at multiple multinational centres.
This study is conducted to evaluate the multicenter investigation comparing the BioMime
Sirolimus Drug Eluting stent with XIENCE family of (Abbott Vascular, Santa Clara, California,
USA) in the treatment of patients with coronary artery disease. Considering that the
randomized studies provide a better comparability and a real efficacy and safety data of the
devices. Subjects will be randomized 2:1 with surrogate endpoints and clinical evaluation.
Subject included in study are eligible to meet the inclusion and exclusion criteria of the
study protocol .The informed consent process will be performed before the subject underwent
for the Procedure. Subject will be treated with treatment allocated by the process of
Randomization. The study follow up will be Seattle angina score evaluation up to 2 years
after the procedure of angioplasty along with the Hospital or telephonic follow up at 1 Month
5month ,1 and 2 years and angiographic follow up at 9 Month.
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