A Post Marketing Registry of ABLUMINUS Sirolimus Eluting Coronary Stent System For Percutaneous Intervention in Patient with Diabetes Mellitus - DEDICATE

Istituto Clinico SantAmbrogio0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

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•1) The patient must be at least 18 years of age;
•2) Diabetic patient having clinical evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia or positive functional study; acute coronary syndromes will be considered);
•3) The patient is an acceptable candidate for percutaneous trans-luminal coronary angioplasty (PTCA) stenting and emergent coronary artery bypass graft (CABG) surgery;
•4) Culprit de novo lesion in a native coronary artery with significant stenosis ( >50% by visual estimate) eligible for stent implantation (no limitation on the number of treated lesions, vessel and lesion length);
•5) Patients included are those for whom the physician has already considered worthwhile the use of Abluminus Stent according to the indications provided by the IFU;
•6) Patient provides written informed consent;
•7) Patient agrees to all required follow-up procedures and visits.

•1) The patient has a known hypersensitivity or contraindication to any of the following medications:Heparin, Aspirin, Both Clopidogrel and TIclopidine, Sirolimus, paclitaxel, ABT 578Stainless steel, Cobalt, biodegradable PLLA polymer;
•2) Patients with hypersensitivity to contrast media who cannot be treated with adequate prophylaxis;
•3) Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study;
•4) Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
•5) History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
•6) Previous coronary intervention on target vessel;
•7) Lesions not allowing a complete balloon inflation or stent deployment;
•8) Non cardiac related any codition in which life expectancy is less than 1 year or may result in protocol non-compliance.

发起方

Istituto Clinico SantAmbrogio