Routine use of cutting/scoring balloon vs. conventional balloon and its impact on stent expansion as evaluated by optical coherence tomography in distal left main bifurcation lesions

Faculty of Medicine, Chiangmai University0 个研究点目标入组 126 人开始时间: 2019年6月21日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Inclusion Criteria:
•18 to 85 years.
•Stable coronary artery disease or silent ischemia demonstrated by positive territorial functional study or clinically stable NSTE-ACS
•Lesion(s) must have a visually estimated diameter stenosis of
•50% and <100%.
•Able to provide written Informed consent and willing to comply with the specified follow-up contacts.
•The patient and the patient physician agree to the follow-up visits up to 12 months.
•Angiographic inclusion criteria:
•Native distal LM bifurcation lesion requiring stent across LM
•Medina Classification X.1.1; X.1.0; 1.0.0; X.0.1
•diameter stenosis 70% or more, as estimated visually
•stenosis of 50% -70% if determined by means of noninvasive or invasive testing to be hemodynamically significant
•LAD or LCX, lesion should locate within 5 mm of the ostium.
•Anatomical SYNTAX score < 33
•If anatomical SYNTAX score more than 33, the patient should be sign-out by the institutional heart team that the patient is indicated to be revascularized with PCI
•Clinical and anatomic eligibility for PCI
•Indication for one-stent technique or two-stent technique
•The length of LM longer than 10 mm by visual estimation

•-Angiographic SYNTAX score more than 33 and heart team signed-out for CABG
•-Recent MI within 48 hours at the time of index procedure
•-LVEF <30%.
•-Killip class II-IV, Cardiogenic shock
•-Prior CABG or planned CABG or need for any concomitant cardiac surgery other than CABG
•- in-stent restenosis
•-Subjects unable to tolerate or comply with dual antiplatelet therapy for at least 12 months
•-Active bleeding or coagulopathy or will receive chronic coagulation therapy
•-Current participation in other investigational drug or device studies that have not reached their primary endpoint
•-Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver cirrhosis
•-Known renal insufficiency CKD stage higher than G3b (eGFR 30-44 ml/min/1.73m2)
•-Known hypersensitivity or contraindication to aspirin, antiplatelet medication specified for use in the study (clopidogrel prasugrel and ticagrelor)
•-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.
•-Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives

发起方

Faculty of Medicine, Chiangmai University