An Evaluation of BioMime™ - Sirolimus Eluting Coronary Stent in a Multi- Centre Study.
NCT ID: NCT02406326
Last Updated: 2018-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
2009-08-27
2016-12-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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.
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.
18 Years
ALL
No
Sponsors
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Meril Life Sciences Pvt. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Ashok Seth, FRCP, FACC,FMRCP, MBBS
Role: PRINCIPAL_INVESTIGATOR
Fortis Escorts Heart Institute & Research Centre
Dr. Ajit Mullasari, DNB, DM, MD, MBBS
Role: PRINCIPAL_INVESTIGATOR
Madras Medical Mission
Dr. Rohit M Kumar, DM, MD, MBBS
Role: PRINCIPAL_INVESTIGATOR
Advance Cardiac Centre
Dr. Samuel K Mathew, DM, MD, MBBS
Role: PRINCIPAL_INVESTIGATOR
Apollo Group of Hospitals
Dr. G S Wander, DM, MD, MBBS
Role: PRINCIPAL_INVESTIGATOR
Hero DMC Heart Institute
Dr. C. N. Manjunath, DM, MD, MBBS
Role: PRINCIPAL_INVESTIGATOR
Sri Jayadeva Institute of Cardiovascular Sciences & Research
Dr. Thomas Alexander, FCSI, FICC, FACC, DM, MD, MBBS
Role: PRINCIPAL_INVESTIGATOR
Kovai Medical Centre and Hospitals Ltd
Dr. Suresh Vijan, MRCP, MD, MBBS
Role: PRINCIPAL_INVESTIGATOR
Fortis/Wockhardt Hospital
Dr. Suhas Hardas, DM, MD, MBBS
Role: PRINCIPAL_INVESTIGATOR
Poona Hopsital & Research Centre
Dr. Sunitha Abraham, DNB, MD, MBBS
Role: PRINCIPAL_INVESTIGATOR
Narayana Hrudayalaya Institute of Medical Sciences
Dr. Prabhakar Shetty, FACC, DM, MD, MBBS
Role: PRINCIPAL_INVESTIGATOR
Columbia Asia Hospitals
Locations
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Columbia Asia Hospitals
Bangalore, Karnataka, India
Sri Jayadeva Institute of Cardiovascular Sciences & Research
Bangalore, Karnataka, India
Narayana Hrudayalaya Institute of Medical Sciences
Bangalore, Karnataka, India
Fortis/Wockhardt Hospital
Mumbai, Maharashtra, India
Poona Hopsital & Research Centre
Pune, Maharshtra, India
Fortis Escorts Heart Institute & Research Centre
New Delhi, National Capital Territory of Delhi, India
Advance Cardiac Centre
Chandigarh, Punjab, India
Hero DMC Heart Institute
Ludhiana, Punjab, India
Madras Medical Mission
Chennai, Tamil Nadu, India
Apollo Group of Hospitals
Chennai, Tamil Nadu, India
Kovai Medical Centre and Hospitals Ltd
Coimbatore, Tamil Nadu, India
Countries
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Related Links
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Other Identifiers
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BIO1TR/MLS/100209
Identifier Type: -
Identifier Source: org_study_id
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