clinical trial · NCT07270562
ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia
Cardiovascular and Interventional Radiological Society of Europe·—·not yet recruiting·n = 250
Chronic Limb Threatening IschemiaChronic Limb-Threatening IschemiaStealth 360™ Peripheral Orbital Atherectomy System from Abbott
brief summary
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.
started
Aug 1, 2026
primary completion
Aug 1, 2031
completion
Dec 1, 2031
last updated
Jul 2, 2026
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol