ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia

ORACLE is a Europe-wide study that will follow 250 people with critical limb-threatening ischemia (CLTI). It aims to see how well orbital atherectomy (OA) works in real-life practice. OA is a procedure that uses a tiny spinning tool to gently remove hard calcium from inside an artery, helping to open the vessel so other treatments-like balloons or stents-can work better. The study focuses on people who have heavily calcified arteries in the femoropopliteal or infrapopliteal areas of the leg.

NCT Number	NCT07270562
Lead Sponsor	Cardiovascular and Interventional Radiological Society of Europe Collaborators: Abbott
Conditions	Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
Enrollment	250 participants
Start Date	2026-08
Primary Completion	2031-08 (estimated)
Study Completion	2031-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-02