BioMime Vs. Xience Randomised Control Clinical Study (meriT-V)

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Sirolimus Eluting Coronary Stent; Device: Everolimus-eluting Coronary stent

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.

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Western Europe
    • Bonheiden, Western Europe, Belgium, 2820
      • Imelda Ziekenhuis Cardiology
• Brazil
  • Sao Paulo, Brazil, 04012-909
    • Instituto Dante Pazzanese de Cardiologia
  • São Paulo, Brazil, 05403-000
    • Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica
  • Uberlândia, Brazil, 38411-186
    • Instituto do Coração do Triângulo Mineiro
• Czechia
  • Brno, Czechia, 602 00
    • Fn Brno, Jihlavska 20
  • Brno
    • Brno-střed, Brno, Czechia, 656 91
      • St. Anne's Univeristy Hospital Brno
• Latvia
  • Europe
    • Riga, Europe, Latvia, LV1002
      • University of Latvia, Research Institute of Cardiology
• Macedonia, The Former Yugoslav Republic of
  • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
    • University Clinic of Cardiology
• Netherlands
  • Zwolle, Netherlands, 8025
    • Isala Hospital
  • North Brabant
    • Eindhoven, North Brabant, Netherlands, 5623
      • Catharina Cardiac Centre
  • South Holland
    • Dordrecht, South Holland, Netherlands, 3300
      • Albert Schweitzer
• Poland
  • Silesia
    • Tychy, Silesia, Poland, 43-100
      • American Heart Institure S.A.
• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Hospital Clinic
• United Kingdom
  • England
    • Bournemouth, England, United Kingdom, BH7 7DW
      • Royal Bournemouth Hospital
    • Manchester, England, United Kingdom, M13 9WL.
      • Manchester Heart Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient must be ≥18 years of age.
• Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris (Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia
• The patient has a planned intervention of up to two de-novo native lesions
• Target lesion reference diameter ≥ 2.5 mm and ≤ 3.5 mm in diameter (visually estimated)
• The target lesion length is less than or equal to 46 mm (visually estimated)
• Patient willing to provide written informed consent.
• If the patient is a female, she should be without childbearing potential who has undergone surgical sterilization or is post-menopausal.
• The patient and the patient's physician agree to the follow-up visits including a 9 month angiographic follow-up.

Exclusion Criteria:

• Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure, unless the CK and CK-MB enzymes are less than twice the Upper Normal Limit.
• The patient has a known hypersensitivity or contraindication to any of the requisite medications including aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus, everolimus.
• There is an untreated significant lesion of > 40% diameter stenosis remaining proximal or distal to the target site after the planned intervention.
• Previous placement of any stent at the target lesion and/or within 10 mm of the target lesion.
• Lesion with a significant side branch (branch diameter >2 mm) that would be covered by stenting
• Total occlusion or TIMI 0 coronary flow in the target vessel.
• Left Main coronary artery disease (stenosis >50%)
• The proximal target vessel or target lesion is severely calcified by visual assessment.
• Aorto-ostial location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the LAD or LCX.
• The patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• The patient suffered a stroke, transient ischemic neurological attack (TIA) or significant gastrointestinal (GI) bleed within the past 6 months
• The patient has renal insufficiency as determined by a creatinine of > 2.0mg/dl or 180 µmol/l.
• The target lesion, or the target vessel proximal to the target lesion contains thrombus
• Documented left ventricular ejection fraction of ≤30%
• The patient is a recipient of a heart transplant
• The patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion or extreme angulations of the vessel at accesslocation (< 45 degrees)
• The patient has other medical illness (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life expectancy (i.e., less than one year)
• The patient is simultaneously participating in another investigational device or drug study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sirolimus Eluting Coronary Stent; BioMime Sirolimus Eluting Stent of Meril Life Sciences	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.; Other Names: BioMime Sirolimus Eluting Stent
Active Comparator: Everolimus-eluting Coronary stent; XIENCE family (V, Xpedition or Prime) of Everolimus-eluting stent system of Abbott Vascular Inc.	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).; Other Names: XIENCE family of Everolimus-eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Binary restenosis by Angiography	Binary Restenosis (DS ≥50%)	9 months
Minimum Lumen Diameter by Angiography	MLD and %DS post procedure at 9 months as compared with pre procedure baseline and post procedure	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.	9 months
Clinical Evaluation	Major Adverse Cardiac Events (MACE)	1, 5, 9, 12 and 24 months

Collaborators and Investigators

• Sponsor: Meril Life Sciences Pvt. Ltd.
• Investigators: Principal Investigator: Dr. Alexandre Abizaid, Ph.D, MD, Instituto Dante Pazzanese de Cardiologia; Principal Investigator: Dr. Roberto V Botelho, MD, Instituto do Coração do Triângulo Mineiro; Principal Investigator: Dr. Pedro Lemos, MD, Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica; Principal Investigator: Dr. Expedito Ribeiro, MD, Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica; Principal Investigator: Dr. Elvin Kedhi, Ph.D, MBBS, Isala; Principal Investigator: Dr. Pim Tonino, MD, Catharina Cardiac Centre; Principal Investigator: Dr. Floris Kauer, MD, Albert Schweitzer; Principal Investigator: Dr. Luc Janssen, MD, Imelda Ziekenhuis Cardiology; Principal Investigator: Dr. Farzin F Ordoubadi, B.Sc, MB BCHIR, MRCP, MD, FRCP, Manchester Heart Centre; Principal Investigator: Dr. Suneel Talwar, MBBS, MRCP, MD, Royal Bournemouth Hospital; Principal Investigator: Dr. Monica Masotti, MD, Hospital Clinic; Principal Investigator: Dr. Andrejs Erglis, MD, University of Latvia, Research Institute of Cardiology; Principal Investigator: Prof. Sasko Kedev, Ph.D, MD, FESC, FACC, University Clinic of Cardiology; Principal Investigator: Dr. Ota Hlinomaz, Ph.D, MD, St. Anne's Univeristy Hospital Brno; Principal Investigator: Dr. Petr kala, Ph.D, MD, FESC, FSCAI, Fn Brno, Jihlavska 20; Principal Investigator: Dr. Krzysztof Milewski, Ph.D, MD, American Heart Institure S.A.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2014
• Primary Completion (Actual): September 6, 2017
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: March 22, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimate): April 14, 2014

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Coronary Arteriosclerosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Everolimus; Sirolimus
• Other Study ID Numbers: BioM/RCT/12/03; 2013-005353-67 (EudraCT Number)