Orbital Atherectomy to Prep Calcified Leg Arteries in CLTI Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ORACLE is an observational cohort study following about 250 CLTI patients across Europe to see how orbital atherectomy with the Stealth 360 system performs in real-world practice. The focus is on calcified femoropopliteal or infrapopliteal lesions and how OA prepares vessels for subsequent treatments like balloons or stents. Data collected will reflect safety, feasibility, and preliminary effectiveness in everyday clinical use. Eligible participants have Rutherford class 4 or higher and show calcification on imaging. The study is sponsored by the Cardiovascular and Interventional Radiological Society of Europe with Abbott as a collaborator and is located at Hull University Teaching Hospitals NHS Trust in the UK.

Why it matters

Who can join: the full rules

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).

Where it's running

• Hull University Teaching Hospitals NHS Trust
  Hull, United Kingdom Recruiting

Study contacts

• Study coordinator: Claire Poulet, PhD
• Email: oracue@cirse.org
• Phone: +41 79 385 16 78

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.