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Recruiting NCT07019350

Smart Angioplasty Research Team-Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion With Drug-Coated Balloon

Trial Parameters

Condition Coronary Artery Disease
Sponsor Samsung Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 520
Sex ALL
Min Age 19 Years
Max Age N/A
Start Date 2025-10-22
Completion 2030-12-31
Interventions
Upfront DCB-based hybrid strategyUpfront 2-stenting strategy

Brief Summary

A prospective, multi-center, open-label, randomized controlled, superiority trial. The aim of the study is to compare clinical outcomes between upfront 2-stenting strategy versus upfront drug-coated balloon (DCB)-based hybrid strategy in patients with complex coronary bifurcation with clinically relevant side branch lesions.

Eligibility 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 * Hemodynamically unstable

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