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

NCT02406326 | Completed

• 1 other identifier: BIO1TR/MLS/100209
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Major Adverse Cardiac Events (MACE)

  Until 12 months

• Device related SAEs

  Until 12 months

• Angioghraphic stent thrombosis

  After 30 days until 12 months

• Angiographic/Device success, Procedural Success, Clinically justified Target Lesion Revascularization

  At 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Women of childbearing potential;
• Impaired renal function (creatinine \> 2.0 mg/dl or 180 μmol/l);
• 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;
• Recipient of an organ (Heart, Kidney, Lung or Liver) transplant;
• History of CVA or TIA within the last 3 months
• Patient with a concomitant disease having a life expectancy of less than 12 months;
• Known allergies or contraindication to mTOR inhibitor class of drugs (Sirolimus), Aspirin, Clopidogrel Bisulphate (Plavix®), Heparin, Cobalt Chromium/Nickel, contrast media;
• 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;
• Clinically relevant contraindication to aspirin, heparin, clopidogrel bisulphate, including thrombocytopenia, neutropenia, or leukopenia
• Patients with Cardiogenic Shock.
• Left main coronary artery disease with ≥ 50% stenosis,
• 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.),
• Left Ventricular Ejection Fraction ≤30 %,
• Saphenous Vein Graft Interventions, (S.V.G's)
• Patients presenting with an ongoing Acute Myocardial Infarction (AMI),

Sponsors & Collaborators

• Meril Life Sciences Pvt. Ltd.: lead

Study Sites (11)

Columbia Asia Hospitals

Bangalore, Karnataka, 560055, India

Location

Sri Jayadeva Institute of Cardiovascular Sciences & Research

Bangalore, Karnataka, 560069, India

Location

Narayana Hrudayalaya Institute of Medical Sciences

Bangalore, Karnataka, 560099, India

Location

Fortis/Wockhardt Hospital

Mumbai, Maharashtra, 400011, India

Location

Poona Hopsital & Research Centre

Pune, Maharshtra, 411030, India

Location

Fortis Escorts Heart Institute & Research Centre

New Delhi, National Capital Territory of Delhi, 110025, India

Location

Advance Cardiac Centre

Chandigarh, Punjab, 160012, India

Location

Hero DMC Heart Institute

Ludhiana, Punjab, 141001, India

Location

Madras Medical Mission

Chennai, Tamil Nadu, 600037, India

Location

Apollo Group of Hospitals

Chennai, Tamil Nadu, 600081, India

Location

Kovai Medical Centre and Hospitals Ltd

Coimbatore, Tamil Nadu, 641014, India

Location

Related Links

• Study results at 12 month follow up

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 2, 2015
• Study Start: August 27, 2009
• Primary Completion: December 27, 2016
• Study Completion: December 27, 2016
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

IN (11)