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

August 16, 2018 updated by: Meril Life Sciences Pvt. Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
256

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To assess in-stent Late Lumen Loss
Time Frame: 9 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of Binary restenosis by Angiography
Time Frame: 9 months
Binary Restenosis (DS ≥50%)
9 months
Minimum Lumen Diameter by Angiography
Time Frame: 9 months
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
Time Frame: 9 months
In-segment Late Lumen Loss at 9 months in-segment and proximal and distal stent margins.
9 months
Clinical Evaluation
Time Frame: 1, 5, 9, 12 and 24 months
Major Adverse Cardiac Events (MACE)
1, 5, 9, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Meril Life Sciences Pvt. Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BioM/RCT/12/03
  • 2013-005353-67 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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