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Comparison of PROVISIONal 1-stent Strategy with DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
Sponsor: Saint Vincent's Hospital, Korea
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).
Official title: Comparison of PROVISIONal 1-stent Strategy with Drug-Eluting Balloon Versus Planned 2-stent Strategy in Patients with Non-LM Coronary True-Bifurcation Lesions.
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
750
Start Date
2023-09-08
Completion Date
2028-12-31
Last Updated
2025-02-10
Healthy Volunteers
No
Interventions
Procedure: planed 2-stent strategy
Procedure: planed 2-stent strategy
Procedure: provisional 1-stent plus DEB strategy
Procedure: provisional 1-stent plus DEB strategy
Locations (1)
St. Vincent's Hospital , the Catholic University
Suwon, Gyeonggi-do, South Korea