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

Cardiovascular and Interventional Radiological Society of Europe

Status: Begins enrollment in 1 month

Conditions: Chronic Limb Threatening Ischemia; Chronic Limb-Threatening Ischemia

Treatments: Device: Stealth 360™ Peripheral Orbital Atherectomy System from Abbott

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07270562

ORACLE

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

250 participants in 1 patient group

Adult CLTI patients with femoropopliteal or infrapopliteal calcified lesions

Description:

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

Treatment:

Device: Stealth 360™ Peripheral Orbital Atherectomy System from Abbott