ANO+_OCT Study - NANO+

epu Medical0 个研究点目标入组 27 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1) 18 to 85 years;
•2) Evidence of myocardial ischemia without raised troponin (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study);
•3) The patient has a planned intervention of up to two de novo lesions, in different epicardial vessels;
•4) Lesion(s) must have a visually estimated diameter stenosis of >=50% and <100%;
•5) Lesion length must be <18mm;
•6) RVD must be between 2.5-4.0 mm;
•7) Written informed consent;
•8) The patient and the patient*s physician agree to the follow-up visits including angiographic follow-up and OCT controls at 3 months.

•1) Evidence of ongoing acute myocardial infarction in ECG prior to procedure;
•2) LVEF <30%;
•3) 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) Known renal insufficiency (e.g., eGFR <60 ml/kg/m2 or serum creatinine level of >2.5 mg/dL, or subject on dialysis);
•5) History of bleeding diathesis or coagulopathy;
•6) The patient is a recipient of a heart transplant;
•7) Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel prasugrel, ticagrelor and ticlopidine), sirolimus or stainless steel;
•8) Other medical illness (e.g. cancer, stroke with neurological deficiency) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy;
•9) Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives.

发起方

epu Medical