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.
Rutherford classification category ≥4;
Treatment of femoropopliteal or infrapopliteal calcified lesions with OA using the Stealth 360 peripheral OA System;
Calcification of target lesions must be visible on fluoroscopy or CT-angiography;
Patients competent and willing to provide informed consent.
Minors and other vulnerable populations who may not be able to give informed consent freely or for whom participation is not essential to the study (incapacitated and unconscious individuals, persons deprived of liberty, pregnant and breastfeeding women, etc.);
Inadequate inflow (>30% stenosis) following optimization;
Insufficient direct outflow (less than 1 run-off vessel);
Endovascular procedure(s) on the treatment site within 4 weeks before index procedure;