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

NCT02406326 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2018-04-11

No results posted yet for this study

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

Sponsors & Collaborators

  • Meril Life Sciences Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr. Ashok Seth, FRCP, FACC,FMRCP, MBBS · Fortis Escorts Heart Institute & Research Centre

  • Dr. Ajit Mullasari, DNB, DM, MD, MBBS · Madras Medical Mission

  • Dr. Rohit M Kumar, DM, MD, MBBS · Advance Cardiac Centre

  • Dr. Samuel K Mathew, DM, MD, MBBS · Apollo Group of Hospitals

  • Dr. G S Wander, DM, MD, MBBS · Hero DMC Heart Institute

  • Dr. C. N. Manjunath, DM, MD, MBBS · Sri Jayadeva Institute of Cardiovascular Sciences & Research

  • Dr. Thomas Alexander, FCSI, FICC, FACC, DM, MD, MBBS · Kovai Medical Centre and Hospitals Ltd

  • Dr. Suresh Vijan, MRCP, MD, MBBS · Fortis/Wockhardt Hospital

  • Dr. Suhas Hardas, DM, MD, MBBS · Poona Hopsital & Research Centre

  • Dr. Sunitha Abraham, DNB, MD, MBBS · Narayana Hrudayalaya Institute of Medical Sciences

  • Dr. Prabhakar Shetty, FACC, DM, MD, MBBS · Columbia Asia Hospitals

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-27
Primary Completion
2016-12-27
Completion
2016-12-27

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02406326 on ClinicalTrials.gov