An Evaluation of BioMime™ - Sirolimus Eluting Coronary Stent in a Multi- Centre Study. (meriT-2)

April 9, 2018 updated by: Meril Life Sciences Pvt. Ltd.

A Prospective Evaluation of BioMime™ - Sirolimus Eluting Coronary Stent in a Multi- Centre Study.

This is a multi centre, prospective trial. 250 patients will be enrolled in the study.(10 patients per centre involving approximately 25 centres). Patients will be followed up clinically for twelve months post-procedure at 1 month, 6 months & 12 months. All patients will have a repeat angiography at 8 months. Clinical follow-up will be maintained for years 3 & 5 post-implant.

Study Overview

Status

Status

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

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.

Detailed Description

This is a multi centre, prospective observational study. 250 patients will be enrolled in the study. 10 patients per centre involving approximately 25 centres. All the patients will be followed for twelve months post-procedure. All patients will have a repeat angiography assessment at 8 months. An additional clinical follow-up will be maintained for years 3 & 5 post-implant.

Approximately 250 patients with obstructive coronary artery disease with a vessel size between ≥2.5 to ≤3.5 mm in diameter by visual estimate and who meet all eligibility criteria will be treated with the Sirolimus Eluting Stent.

It is anticipated that the total length of the study will be 16 months: 4 months to complete patient enrollment and 12 months for angiographic follow-up.

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.
Observational

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.
250

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

  • India
    • Delhi
      • New Delhi, Delhi, India, 110025
        • Fortis Escorts Heart Institute & Research Centre
    • Karnataka
      • Bangalore, Karnataka, India, 560055
        • Columbia Asia Hospitals
      • Bangalore, Karnataka, India, 560069
        • Sri Jayadeva Institute of Cardiovascular Sciences & Research
      • Bangalore, Karnataka, India, 560099
        • Narayana Hrudayalaya Institute of Medical Sciences
    • Maharashtra
      • Mumbai, Maharashtra, India, 400011
        • Fortis/Wockhardt Hospital
    • Maharshtra
      • Pune, Maharshtra, India, 411030
        • Poona Hopsital & Research Centre
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Advance Cardiac Centre
      • Ludhiana, Punjab, India, 141001
        • Hero DMC Heart Institute
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600037
        • Madras Medical Mission
      • Chennai, Tamil Nadu, India, 600081
        • Apollo Group of Hospitals
      • Coimbatore, Tamil Nadu, India, 641014
        • Kovai Medical Centre and Hospitals Ltd

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

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of 250 patients with an obstructive coronary artery disease with few exclusion criteria.

Description

Inclusion Criteria:

  1. The patient must be ≥18 years of age;
  2. Patient is an acceptable candidate for PTCA, Stenting, or Emergent CABG;
  3. Symptomatic ischemic heart disease (CCS class 1-4 , Braunwald class IB, IC, IIB, IIC,IIIB,IIIC) and/or objective evidence of myocardial ischemia;
  4. TIMI (Thrombolysis In Myocardial Infarction) flow grade ≥ 2 ;
  5. C.T.O's (Chronic Total Occlusions) and Bifurcation Lesions may also be attempted;
  6. Target lesion stenosis is >50% and <100% ;
  7. Target lesions are de novo;
  8. Target lesions ≤ 35mm in length (by visual estimation) that can be treated (covered) by one single study stent (13 to 40mm in length)
  9. Target lesion located in a major epicardial coronary vessel with reference of ≥ 2.5 - ≤ 3.5mm in diameter (by visual estimation)
  10. Target lesions which can be covered by one stent, no overlapping allowed (lesion stent ratio of at least 1.5)
  11. The patient and/or his legal representative has been informed of the nature of the study and agrees to its provisions and has provided a written informed consent.

Exclusion Criteria:

General exclusion criteria:

  1. Women of childbearing potential;
  2. Impaired renal function (creatinine > 2.0 mg/dl or 180 μmol/l);
  3. Any patient who has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of Hepatitis;
  4. Recipient of an organ (Heart, Kidney, Lung or Liver) transplant;
  5. History of CVA or TIA within the last 3 months
  6. Patient with a concomitant disease having a life expectancy of less than 12 months;
  7. Known allergies or contraindication to mTOR inhibitor class of drugs (Sirolimus), Aspirin, Clopidogrel Bisulphate (Plavix®), Heparin, Cobalt Chromium/Nickel, contrast media;
  8. Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study such as an active infection or peptic ulcer or upper GI bleeding;
  9. Currently participating in an investigational drug or another device study, or subject to inclusion in another investigational drug or another device study during follow-up.
  10. Clinically relevant contraindication to aspirin, heparin, clopidogrel bisulphate, including thrombocytopenia, neutropenia, or leukopenia
  11. Patients with Cardiogenic Shock.

Angiographic Exclusion criteria:

  1. Left main coronary artery disease with ≥ 50% stenosis,
  2. Angiographic evidence of thrombus (thrombus larger than half the diameter of the vessel and/or requiring other adjunctive interventions such as Angiojet, Exciser, Thrombolysis, etc.),
  3. Left Ventricular Ejection Fraction ≤30 %,
  4. Saphenous Vein Graft Interventions, (S.V.G's)
  5. Patients presenting with an ongoing Acute Myocardial Infarction (AMI),
  6. Patients having undergone a PCI within 48 hours of an AMI episode.

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

  • Observational Models: Other
  • Time Perspectives: Prospective

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
Major Adverse Cardiac Events (MACE) days
Time Frame: 30 days
composite of Death, MI (both Q-wave and Non Q-wave MI), Emergent CABG, or Clinically driven TLR (repeat PCI or CABG) and measured percentage wise
30 days

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
Major Adverse Cardiac Events (MACE)
Time Frame: Until 12 months
Major adverse cardiac events is defined as the aggregate of cardiac death, myocardial infarction (MI) attributed to target vessel, and any target lesion revascularization (TLR)
Until 12 months
Device related SAEs
Time Frame: Until 12 months
Serious Adverse Events
Until 12 months
Angioghraphic stent thrombosis
Time Frame: After 30 days until 12 months
Acute (In hospital), Subacute (post procedure until 30 days) and Late (after 30 days until 12 months)
After 30 days until 12 months
Angiographic/Device success, Procedural Success, Clinically justified Target Lesion Revascularization
Time Frame: At 12 months
Quantitative Coronary Angiography derived vessel parameters In stent and 5 mm proximal and 5 mm distal from the edge of the stent (In-segment), Acute Gain (mm), Mild (%), Late loss (mm) and Binary Restenosis (%) rate, In stent MLD pre, post and 8 months angiographic follow up.
At 12 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. Ashok Seth, FRCP, FACC,FMRCP, MBBS, Fortis Escorts Heart Institute & Research Centre
  • Principal Investigator: Dr. Ajit Mullasari, DNB, DM, MD, MBBS, Madras Medical Mission
  • Principal Investigator: Dr. Rohit M Kumar, DM, MD, MBBS, Advance Cardiac Centre
  • Principal Investigator: Dr. Samuel K Mathew, DM, MD, MBBS, Apollo Group of Hospitals
  • Principal Investigator: Dr. G S Wander, DM, MD, MBBS, Hero DMC Heart Institute
  • Principal Investigator: Dr. C. N. Manjunath, DM, MD, MBBS, Sri Jayadeva Institute of Cardiovascular Sciences & Research
  • Principal Investigator: Dr. Thomas Alexander, FCSI, FICC, FACC, DM, MD, MBBS, Kovai Medical Centre and Hospitals Ltd
  • Principal Investigator: Dr. Suresh Vijan, MRCP, MD, MBBS, Fortis/Wockhardt Hospital
  • Principal Investigator: Dr. Suhas Hardas, DM, MD, MBBS, Poona Hopsital & Research Centre
  • Principal Investigator: Dr. Sunitha Abraham, DNB, MD, MBBS, Narayana Hrudayalaya Institute of Medical Sciences
  • Principal Investigator: Dr. Prabhakar Shetty, FACC, DM, MD, MBBS, Columbia Asia Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
August 27, 2009

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.
December 27, 2016

Study Completion (Actual)

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 27, 2016

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 30, 2015

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 1, 2015

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 2, 2015

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.
April 11, 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.
April 9, 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.
April 1, 2018

More Information

Terms related to this study

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.
  • BIO1TR/MLS/100209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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