NCT07270562From ClinicalTrials.govRecruiting

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

Chronic Limb Threatening Ischemia
Chronic Limb-Threatening Ischemia

At a glance

Phase: Phase not stated
Study type: Observational
Sponsor: Cardiovascular and Interventional Radiological Society of Europe
Enrolment target: 250
Started: 31 August 2026
Main results due: August 2031
Study sites: 1
Registry updated: 23 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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).

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07270562. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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