Clinical Trial

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

Study acronym: PROVISIONDEB
Recruiting
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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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-08-17; most recent amendment 2025-02-05.
Trial Details
NCT Number NCT06002932
Lead Sponsor Saint Vincent's Hospital, Korea
Conditions Coronary Artery Disease, Ischemic Heart Disease
Enrollment 750 participants
Start Date 2023-09-08
Primary Completion 2028-07-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-10