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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
256
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.
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).
Imelda Ziekenhuis Cardiology
Bonheiden, Western Europe, Belgium
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica
To assess in-stent Late Lumen Loss
The primary outcome of this study is to assess in-stent Late Lumen Loss at 9 months for both treatment strategies.
Time frame: 9 months
Frequency of Binary restenosis by Angiography
Binary Restenosis (DS ≥50%)
Time frame: 9 months
Minimum Lumen Diameter by Angiography
MLD and %DS post procedure at 9 months as compared with pre procedure baseline and post procedure
Time frame: 9 months
In-segment Late Lumen Loss at 9 months
In-segment Late Lumen Loss at 9 months in-segment and proximal and distal stent margins.
Time frame: 9 months
Clinical Evaluation
Major Adverse Cardiac Events (MACE)
Time frame: 1, 5, 9, 12 and 24 months
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São Paulo, Brazil
Instituto do Coracao do Triangulo Mineiro
Uberlândia, Brazil
St. Anne's Univeristy Hospital Brno
Brno-střed, Brno, Czechia
Fn Brno, Jihlavska 20
Brno, Czechia
University of Latvia, Research Institute of Cardiology
Riga, Europe, Latvia
Catharina Cardiac Centre
Eindhoven, North Brabant, Netherlands
Albert Schweitzer
Dordrecht, South Holland, Netherlands
Isala Hospital
Zwolle, Netherlands
...and 5 more locations