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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-04-30

Study Completion Date

2031-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Limb Threatening Ischemia Chronic Limb-Threatening Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult CLTI patients with femoropopliteal or infrapopliteal calcified lesions

Eligible patients are those who will undergo OA prior to any adjunctive endovascular procedure

Stealth 360™ Peripheral Orbital Atherectomy System from Abbott

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Orbital Atherectomy Orbital Atherectomy System

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No