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

Recruitingn/aAges 18 Years - anyAllCardiovascular and Interventional Radiological So…
NCT07270562 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 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. Exclusion Criteria: 1. 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.); 2. Inadequate inflow (\>30% stenosis) following optimization; 3. Insufficient direct outflow (less than 1 run-off vessel); 4. Endovascular procedure(s) on the treatment site within 4 weeks before index procedure; 5. Patients planned to receive an above ankle amputation of the target limb; 6. Patients enrolled in RESCUE (ClinicalTrials.gov ID NCT07270575).
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What it tests

  • Stealth 360™ Peripheral Orbital Atherectomy System from Abbott
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Where

1 site
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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