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RECRUITING
NCT07019350
NA

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

Sponsor: Samsung Medical Center

View on ClinicalTrials.gov

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.

Official title: Drug-Coated Balloon Versus Drug-eluting Stent for Treatment of Clinically Relevant Side Branch in Complex Coronary Bifurcation Lesion

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

520

Start Date

2025-10-22

Completion Date

2030-12-31

Last Updated

2025-11-24

Healthy Volunteers

No

Interventions

OTHER

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.

OTHER

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.

Locations (3)

Chonnam National University Hospital

Gwangju, South Korea

Chosun University Hospital

Gwangju, South Korea

Samsung Medical Center

Seoul, South Korea