COMBINEd Ischemia and Vulnerable PlaquePercutaneous INTERVENtion to Reduce Cardiovascular Events - COMBINE-INTERVE

Erasmus Academical Hospital Universit Libre de Bruxelles0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年8月21日

试验速览

暂无简介。

•For this Investigator initiated study below are the inclusion criteria
•1. Patients undergoing PCI, aged 30-80 years with any clinical presentation
•2. Angiographic criteria: = 2 de novo target lesions located in 2 different native coronary arteries feasible for treatment with PCI (operator / Heart team decision)
•Angiographic criteria target lesion (all criteria I-IV should be applicable):
•I. Diameter stenosis (DS) = 50%
•II. De novo lesion located in native (non-grafted) vessel
•III. lesion reference diameter of = 2.0 mm
•IV. Thrombolysis In Myocardial Infarction (TIMI) 3 flow in all vessels
•(with exclusion of culprit lesions in patients with MI)

•For this Investigator initiated study below are the exclusion criteria
•1. Patients with MVD requiring coronary artery bypass grafting (CABG) treatment(operator / local heart team decision)
•2. Lesion located in a grafted segment or in a vein graft
•3. In-stent restenosis lesions
•4. Left main trifurcation
•5. Left main lesion stand-alone (without another lesion)
•6. Patients with severe tortuous lesions (where FFR and OCT is judged impossible or dangerous)
•7. Chronic total occlusion
•8. Spontaneous coronary dissection
•9. Patients with severe valvular heart disease likely to require cardiac surgery within the next 2 years
•10. Patients with left ventricle (LV) function less than 30%
•Renal insufficiency (Glomerular Filtration Rate (GFR) < 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5)
•11. Life expectancy less than 3 years

发起方

Erasmus Academical Hospital Universit Libre de Bruxelles