NCT06002932

Comparison of PROVISIONal 1-stent Strategy with DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.

Comparison of PROVISIONal 1-stent Strategy with Drug-Eluting Balloon Versus Planned 2-stent Strategy in Patients with Non-LM Coronary True-Bifurcation Lesions.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Saint Vincent's Hospital, Korea · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

\[The Purpose of the Clinical Study\] The purpose of this randomized comparison study is to compare the 1-stent strategy with a drug-eluting balloon and the 2-stent strategy in patients with non-LM coronary true-bifurcation lesions. \[Hypothesis\] In this study, the researchers intend to verify the hypothesis that the 1-stent strategy with a drug-eluting balloon is non-inferior to the 2-stent strategy in terms of target lesion failures (cardiac death, target vessel MI, or target vessel revascularization).

Detailed description

1. Provisional 1-stent plus DEB strategy As a principal, the treatment regime will be composed of the stent treatment in the main blood vessel and a drug-eluting balloon in a branch vessel. The order of the treatments done to the main vessel and the branch vessel shall be at the discretion of the treatment provider. Also, at the discretion of the treatment provider, a bail-out stenting can still be performed, depending on the condition of the branch vessel following a drug-eluting balloon treatment. However, bail-out stenting is recommended if there is a TIMI flow disorder, severe coronary artery exfoliation (National Heart, Lung, and Blood Institute type D, E, or F), or significant residual stenosis. 2. Planned 2-stent strategy As per the conventional treatment process, this strategy treats both the main vessel and the branch vessel with stents. The decision among Crush (Mini-crush), DK-Crush, Cullotte, TAP, and T-stenting is left to the discretion of the treatment provider.

Conditions

• Coronary Artery Disease
• Ischemic Heart Disease

Interventions

Type	Name	Description
PROCEDURE	Procedure: planed 2-stent strategy	Procedure: planed 2-stent strategy
PROCEDURE	Procedure: provisional 1-stent plus DEB strategy	Procedure: provisional 1-stent plus DEB strategy

Timeline

• Start date: 2023-09-08
• Primary completion: 2028-07-31
• Completion: 2028-12-31
• First posted: 2023-08-21
• Last updated: 2025-02-10

Locations

1 site across 1 country: South Korea