patients with distal LM bifurcation left main, OCT
Conditions
Interventions
The cutting balloon (CB) is a balloon catheter with three or four atherotomes (microsurgical blades) bonded longitudinally to its surface. It is a specialized device designed to create discrete longit
compliance balloon is a balloon catheter that grow and conform less as pressure increased.
Experimental Device,Active Comparator Device
Cutting/Scoring balloon,Non-
compliance balloon
Sponsors
Faculty of Medicine, Chiangmai University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 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 with diameter stenosis 70% or more, as estimated visually or 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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stent expansion periprocedure OCT measurement | — |
Secondary
| Measure | Time frame |
|---|---|
| Target vessel failure 12-month follow-up clinical and angiography,angiographic endpoints post-procedure QCA | — |
Countries
Thailand
Contacts
Public Contactpannipa suwannasom
Chiang Mai University
Outcome results
None listed