BioMime Vs. Xience Randomised Control Clinical Study

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.

Conditions

• Coronary Artery Disease

Interventions

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).

Sponsors & Collaborators

• Meril Life Sciences Pvt. Ltd.

  lead INDUSTRY

Principal Investigators

• Dr. Alexandre Abizaid, Ph.D, MD · Instituto Dante Pazzanese de Cardiologia

• Dr. Roberto V Botelho, MD · Instituto do Coracao do Triangulo Mineiro

• Dr. Pedro Lemos, MD · Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica

• Dr. Expedito Ribeiro, MD · Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica

• Dr. Elvin Kedhi, Ph.D, MBBS · Isala

• Dr. Pim Tonino, MD · Catharina Cardiac Centre

• Dr. Floris Kauer, MD · Albert Schweitzer

• Dr. Luc Janssen, MD · Imelda Ziekenhuis Cardiology

• Dr. Farzin F Ordoubadi, B.Sc, MB BCHIR, MRCP, MD, FRCP · Manchester Heart Centre

• Dr. Suneel Talwar, MBBS, MRCP, MD · Royal Bournemouth Hospital

• Dr. Monica Masotti, MD · Hospital Clinic

• Dr. Andrejs Erglis, MD · University of Latvia, Research Institute of Cardiology

• Prof. Sasko Kedev, Ph.D, MD, FESC, FACC · University Clinic of Cardiology

• Dr. Ota Hlinomaz, Ph.D, MD · St. Anne's Univeristy Hospital Brno

• Dr. Petr kala, Ph.D, MD, FESC, FSCAI · Fn Brno, Jihlavska 20

• Dr. Krzysztof Milewski, Ph.D, MD · American Heart Institure S.A.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-05

Primary Completion

2017-09-06

Completion

2019-12-01

Countries

• Belgium
• Brazil
• Czechia
• Latvia
• Netherlands
• North Macedonia
• Poland
• Spain
• United Kingdom

Study Locations