Trials / Not Yet Recruiting
Not Yet RecruitingNCT07270562
ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 250 (estimated)
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Stealth 360™ Peripheral Orbital Atherectomy System from Abbott | The Stealth 360™ Peripheral Orbital Atherectomy System uses a diamond-coated, eccentrically mounted crown with bi-directional capabilities that treat a wide range of vessels, enabling single device treatment of multiple lesions and vessel sizes. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2031-04-01
- Completion
- 2031-12-01
- First posted
- 2025-12-08
- Last updated
- 2026-01-02
Source: ClinicalTrials.gov record NCT07270562. Inclusion in this directory is not an endorsement.