None listed
Conditions
Interventions
Procedure/Surgery : Patients will be screened for eligibility and, if qualified, a written informed consent will be obtained from all patients. After obtaining informed consent, patients will be rando
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Subject must be at least 19 years of age ? Patients with acute or chronic coronary syndrome intended for percutaneous coronary intervention (PCI) ? Patients with de novo complex coronary bifurcation with clinically relevant side branch * Definition of complex coronary bifurcation with clinically relevant side branch is true bifurcation lesion (Medina 1,1,1 / 1,0,1 / 0,1,1) with side branch lesion length =10mm and should meet at least one of the below criteria. i. Left main bifurcation with side branch stenosis severity =70% by visual estimation ii. Non-left main bifurcation with side branch reference vessel diameter =2.75mm and stenosis severity =90% by visual estimation ? Subject who can verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive approach and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Exclusion criteria
Exclusion criteria: ? Hemodynamically unstable condition (SBP <90 mmHg even after administration of vasopressor, ventricular arrhythmias, or cardiogenic shock) ? Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock) ? Known significant congenital, severe valvular or cardiomyopathic (hypertrophic or dilated cardiomyopathy, or any other forms) process which could explain cardiac symptoms. ? Severe left ventricular systolic dysfunction (ejection fraction <30%) ? Intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, or heparin. ? Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator’s medical judgment) ? pregnant and/or lactating women ? Unwillingness or inability to comply with the procedures described in this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first event of MACE (a composite of death, MI, clinically-driven target-vessel revascularization), according to the Academic Research Consortium (ARC) II-consensus | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause death;Cardiac death;Any MI, defined by Forth Universal definition of MI;Spontaneous MI, defined by Forth Universal definition of MI;Procedure-related MI, defined by ARC II definition;Stent thrombosis, defined by ARC II definition;Unplanned revascularization (clinically-driven);Target-vessel revascularization (clinically-driven);Cerebrovascular accidents (ischemic or hemorrhagic);Bleeding (BARC 2, 3, or 5);Seattle Angina Questionnaire;Procedure-related complications during index procedure;Rates of bail-out stenting and crossover rates from upfront Drug-Coated Balloon-based hybrid strategy to upfront 2-stenting strategy | — |
Countries
Korea, Republic of
Contacts
Public ContactDohyeon Kim
Samsung Medical Center
Outcome results
None listed