ClinicaliQ Trial Snapshot
- ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia — Recruiting • Cardiology / Cardiovascular • NCT07270562.
- What is being tested: Orbital atherectomy (OA), a minimally invasive procedure using a small spinning device for plaque removal, is being evaluated in real-world clinical practice for treating critical limb-threatening ischemia (CLTI) across Europe in 250 patients.
- Patient eligibility overview: The trial includes patients with CLTI—severe peripheral artery disease at risk of limb loss—who require intervention to restore blood flow to their lower limbs.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : 1. Rutherford classification category ≥4; 2. Treatment of femoropopliteal or infrapopliteal calcified lesions with OA using the Stealth 360 peripheral OA System; 3. Calcification of target lesions must be visible on fluoroscopy or CT-angiography; 4. Patients competent and willing to provide informed consent.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.