Status:
COMPLETED
A Safety and Efficacy of Supralimus™ Core™ Sirolimus Eluting Stent at MAX DDHV Institute
Lead Sponsor:
Sahajanand Medical Technologies Limited
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
OBJECTIVES: The primary objective of this study is to assess the safety and efficacy of the Supralimus - Core™ Sirolimus Eluting Stent in de novo native vessel obstructive coronary artery disease. S...
Eligibility Criteria
Inclusion
- The patient must be \>= 18 years of age;
- Symptomatic ischemic heart disease (CCS class 1 -4 , Braunwald class IB, IC, IIB, IIC, IIIB,IIIC) and/or objective evidence of myocardial ischemia;
- Vessel size of \>= 2.5 and \<= 3.5mm.
- Target lesions which can be covered by stent in a manner lesion stent ratio of at least 1.5.
- Acceptable candidate for coronary artery bypass surgery (CABG);
- Target lesion stenosis is \>50% and \<100% (TIMI flow I) (visual estimate);
- The patient has been informed of the nature of the study agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC) or Institutional Review Board (IRB).
Exclusion
- Women of childbearing potential;
- Impaired renal function (creatinine \> 2.0 mg/dl or 177 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 heart transplant;
- Restenotic or lesion in graft.
- Patient with a life expectancy less than 12 months;
- Known allergies to aspirin, clopidogrel bisulphate (Plavix), ticlopidine (Ticlid), heparin or stainless steel;
- Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
- 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.
- Angiographic Exclusion criteria:
- Unprotected 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 interventions such as angiojet, exciser, thrombolysis, etc.);
- Ejection fraction \<= 30%;
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00811616
Start Date
July 1 2006
End Date
March 1 2008
Last Update
May 16 2025
Active Locations (1)
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1
Max Heart and Vascular Institute
New Delhi, New Delhi, India, 110017