Clinical Trial

Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

Study acronym: OraBil
Recruiting
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Summary
Clinical research with medical devices indicated in accordance with the CE marking, led by researchers, multicenter, open, prospective, randomized and controlled. Patients are randomized to treatment with a conventional balloon and then a coronary stent or to initial plaque modification with Orbital Atherectomy (OA) and then a coronary stent. To evaluate the efficacy and safety of OA in the adequate treatment with coronary stent of the calcified bifurcation lesion using angiography and optical coherence tomography (OCT).
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2024-12-11; most recent amendment 2026-07-07.
Status change: Not Yet Recruiting → Recruiting 2025-11-14
Trial Details
NCT Number NCT06736899
Lead Sponsor Fundación EPIC
Conditions Coronary Artery Disease, Coronary Disease
Enrollment 200 participants
Start Date 2025-10-23
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-08