NCT02112981

BioMime Vs. Xience Randomised Control Clinical Study

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Meril Life Sciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Sirolimus Eluting Coronary Stent	BioMimeTM Sirolimus Eluting Stent (CE Marked) has cobalt chromium NexGenTM platform (CE Marked) with Tamarin BlueTM balloon Delivery System (CE marked and with FDA clearance under 510k). Stent is coated with combination of Sirolimus drug and Biodegradable PLLA and PDLG polymers.
DEVICE	Everolimus-eluting Coronary stent	Xience V/Xience Xpedition/Xience Prime stent is MULTI-LINK MINI VISION or MULTI-LINK VISION platform Cobalt chromium stent with Everolimus (active ingredient) embedded in a non-erodible polymer (inactive ingredient).

Timeline

• Start date: 2014-11-05
• Primary completion: 2017-09-06
• Completion: 2019-12-01
• First posted: 2014-04-14
• Last updated: 2018-08-17

Locations

15 sites across 9 countries: Belgium, Brazil, Czechia, Latvia, Netherlands, North Macedonia, Poland, Spain, United Kingdom