Smart Angioplasty Research Team-Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion With Drug-Coated Balloon
Condition(s) studied
Investigational drug(s) / intervention(s)
Upfront DCB-based hybrid strategy: In upfront DCB-based hybrid strategy group, stepwise provisional strategy with side branch DCB angioplasty will be performed according to the follow standardized procedural steps. In this group, provisional stenting strategy will be performed in accordance with the European Bifurcation Club (EBC) consensus. Bail-out stenting will be performed using operator's preferred technique (e.g. T, TAP, culotte) when there will be one of the following after hybrid strategy: \<TIMI 3 flow in the side branch, severe (\>90%) ostial pinching, or flow-limiting dissection.
Upfront 2-stenting strategy: In upfront 2-stenting strategy group, systematic planned 2-stenting will be performed according to EBC recommendations. The stent technique will be at the discretion of the operator but could be one of culotte, DK-culotte, mini-crush, DK-crush, T or TAP.
Study 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
Primary outcome measure(s)
- Major Adverse Cardiac Event (MACE) — 1 year after last patient enrollment
MACE (a composite of death, MI, clinically-driven target-vessel revascularization), according to the Academic Research Consortium (ARC) II-consensus.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Chonnam National University Hospital | Gwangju | South Korea | Not Yet Recruiting |
| Chosun University Hospital | Gwangju | South Korea | Not Yet Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
More Samsung Medical Center trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07019350 on ClinicalTrials.gov ↗ ← All trials in South Korea