NCT02112981 - BioMime Vs. Xience Randomised Control Clinical Study | Biotech Hunter

Enrollment

256

Participants

Timeline

Start Date

November 5, 2014

Primary Completion Date

September 6, 2017

Study Completion Date

December 1, 2019

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).

Trial Locations (15)

1000

University Clinic of Cardiology, Skopje

2820

Imelda Ziekenhuis Cardiology, Bonheiden

3300

Albert Schweitzer, Dordrecht

5623

Catharina Cardiac Centre, Eindhoven

8025

Isala Hospital, Zwolle

04012-909

Instituto Dante Pazzanese de Cardiologia, São Paulo

05403-000

Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica, São Paulo

38411-186

Instituto do Coracao do Triangulo Mineiro, Uberlândia

656 91

St. Anne's Univeristy Hospital Brno, Brno střed

602 00

Fn Brno, Jihlavska 20, Brno

LV1002

University of Latvia, Research Institute of Cardiology, Riga

43-100

American Heart Institure S.A., Tychy

08036

Hospital Clinic, Barcelona

BH7 7DW

Royal Bournemouth Hospital, Bournemouth

M13 9WL.

Manchester Heart Centre, Manchester