NCT07270562 ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia
| NCT ID | NCT07270562 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cardiovascular and Interventional Radiological Society of Europe |
| Condition | Chronic Limb Threatening Ischemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-08-31 |
| Primary Completion | 2031-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2026-08-31 with a primary completion date of 2031-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Gerd Grözinger, Prof. Dr. med.
STUDY CHAIR
SLK Kliniken Heilbronn GmbH
Frequently Asked Questions
Who can join the NCT07270562 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Limb Threatening Ischemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07270562 currently recruiting?
Yes, NCT07270562 is actively recruiting participants. Contact the research team at oracue@cirse.org for enrollment information.
Where is the NCT07270562 trial being conducted?
This trial is being conducted at Hull, United Kingdom.
Who is sponsoring the NCT07270562 clinical trial?
NCT07270562 is sponsored by Cardiovascular and Interventional Radiological Society of Europe. The principal investigator is Gerd Grözinger, Prof. Dr. med. at SLK Kliniken Heilbronn GmbH. The trial plans to enroll 250 participants.