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

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: Completed
• Conditions: Coronary Artery Disease

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: Observational
• Enrollment (Actual): 250

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac Events (MACE) 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

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac Events (MACE)	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	Serious Adverse Events	Until 12 months
Angioghraphic stent thrombosis	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	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

• Sponsor: Meril Life Sciences Pvt. Ltd.
• Investigators: 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

Helpful Links

• Study results at 12 month follow up

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2009
• Primary Completion (Actual): December 27, 2016
• Study Completion (Actual): December 27, 2016

Study Registration Dates

• First Submitted: March 30, 2015
• First Submitted That Met QC Criteria: April 1, 2015
• First Posted (Estimate): April 2, 2015

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: BIO1TR/MLS/100209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided