CTRI/2012/04/002612
Recruiting
Phase 4
A Prospective Multi-Centre Registry to Investigate Safety and Effectiveness of Mâ??Sure S (Sirolimus Eluting Coronary Stent). - PRISM
Multimedics0 sites400 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Multimedics
- Enrollment
- 400
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.The patient must be ï?³ 18 years of age;
- •2\.Patient is an acceptable candidate for PTCA, Stenting, or Emergent CABG;
- •3\.Symptomatic ischemic heart disease (CCS class 1 â??4 , Braunwald class IB, IC, IIB, IIC, IIIB,IIIC) and/or objective evidence of myocardial ischemia;
- •4\.C.T.Oâ??s (Chronic Total Occlusions) and Bifurcation Lesions may also be attempted;
- •5\.Target lesion stenosis is \>50% and \<100% ;
- •6\.Target lesions are de novo;
- •7\.Target lesions \<\=36mm in length (by visual estimation) that can be treated (covered) by one single Registry stent (8 to 40mm in length)
- •8\.Target lesion located in a major epicardial coronary vessel with reference of \>2\.5 \- \<4\.0mm in diameter (by visual estimation)
- •9\.Target lesions which can be covered by one stent, no overlapping allowed (lesion stent ratio of at least 1\.5\)
Exclusion Criteria
- •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 (Plavixï??), Heparin, Cobalt Chromium/Nickel,
Outcomes
Primary Outcomes
Not specified
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