A Prospective Multi-Centre Registry to Investigate Safety and Effectiveness of Mâ??Sure S (Sirolimus Eluting Coronary Stent). - PRISM

Multimedics0 个研究点目标入组 400 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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)

•Women of childbearing potential;
•2. Impaired renal function (creatinine > 2.0 mg/dl or 180 Âµmol/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,
•contrast media;
•8. Any significant medical condition which in the investigatorâ??s opinion may interfere
•with the patientâ??s optimal participation in the Registry such as an active infection or
•peptic ulcer or upper GI bleeding;
•9. Currently participating in an investigational drug or another device Registry, or subject
•to inclusion in another investigational drug or another device Registry during follow-
•10. Clinically relevant contraindication to aspirin, heparin, clopidogrel bisulphate, including
•thrombocytopenia, neutropenia, or leukopenia
•11. Patients with Cardiogenic Shock.

发起方

Multimedics