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: REACTION study
- Conditions
- patients with distal LM bifurcationleft main, OCT
- Registration Number
- TCTR20190621001
- Lead Sponsor
- Faculty of Medicine, Chiangmai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 126
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
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stent expansion periprocedure OCT measurement
- Secondary Outcome Measures
Name Time Method Target vessel failure 12-month follow-up clinical and angiography,angiographic endpoints post-procedure QCA