Clinical Trial

Stenting Versus Drug Eluting Balloons Only in Treatment of Coronary Bifurcation Lesion (ROBUST Study)

Study acronym: ROBUST
Not Yet Recruiting
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Summary
The goal of this clinical trial is to learn immediate and follow up results of percutaneous treatment of coronary bifurcation lesion using drug eluting balloons (DEB) only in patients with chronic coronary syndrome (CCS). Researchers will compare endovascular treatment using solely DEB to stenting of coronary bifurcation lesion. The main questions it aims to answer are: * What is immediate and follow up clinical and angiographic results of endovascular treatment of coronary bifurcation lesion using DEB in patients with CCS? * Is efficacy and safety of endovascular treatment of coronary bifurcation lesion using DEB only in patients with CCS non inferior to compare stenting of aforementioned lesion which is contemporary recommended standard of care? Participants will: * Take prescribed medication before and after initial procedure during whole observation period (12 months) * Visit the clinic at 1, 6 and 12 months after the initial procedure for checkup, noninvasive tests and control angiography at 12 months follow up * Inform researchers about all adverse events that might be occur during follow up observation period
Trial Details
NCT Number NCT07552194
Lead Sponsor Avtandil M. Babunashvili
Collaborators: I.M. Sechenov First Moscow State Medical University
Conditions Coronary Artery Disease (CAD), Coronary Bifurcation Lesion, Coronary Stenting, Drug Eluting Balloon
Enrollment 272 participants
Start Date 2026-06-02
Primary Completion 2027-12-20 (estimated)
Study Completion 2028-02-20 (estimated)
Updated on ClinicalTrials.gov 2026-04-27