NCT07019350

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Among complex coronary artery lesions, percutaneous coronary intervention (PCI) for true bifurcation lesions has been challenging to perform and associated with a higher risk of mortality, unplanned repeat revascularization or stent thrombosis.15-17 Although current guidelines recommend 1-stenting with provisional side branch approach as an initial treatment strategy for the bifurcation lesions based on previous trials,11,12,18-22 there are studies that demonstrate better or similar outcomes with the upfront 2-stenting strategy.3,4,21,23 Of note, these trials that have favored upfront 2-stenting strategy have shown a tendency for better efficacy of 2-stenting as the severity of bifurcation lesions increases.3,4,21,23 Considering that the discrepancy among study results could be attributable to the complexity of true bifurcation lesions, it can be argued that 1-stenting with provisional SB approach by conventional balloon dilatation shows limitations in dealing with severely complex true bifurcation lesions. During provisional stenting, unplanned side branch stenting is associated with worse clinical outcomes.24 In addition, SB failure occurred more frequently than main vessel failure in both 1-stenting and 2-stenting group.25 Considering these results, there have been some studies trying to demonstrate the effect of drug-coated balloon (DCB) angioplasty at side branch during the PCI for bifurcation lesions.5,26 In the most recent trial, DCB angioplasty yielded better results compared to conventional simple balloon dilatation.5 Thus, for true bifurcation lesions, upfront DCB-based hybrid strategy could serve as a good alternative treatment strategy that improves clinical outcomes for patients with complex coronary bifurcation lesion with clinically relevant side branch. On this background, this trial sought to compare the clinical outcomes between upfront DCB-based hybrid strategy and upfront 2-stenting strategy in patients with complex coronary bifurcation with clinically relevant side branch.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-22
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2025-06-13
• Last updated: 2025-11-24

Locations

3 sites across 1 country: South Korea