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

NCT07270562 | Not Yet Recruiting

• 1 other identifier: ORACLE
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Limb Threatening Ischemia; Chronic Limb-Threatening Ischemia

Keywords

CLTI; Peripheral artery disease; Orbital atherectomy; Observational cohort study; Chronic limb ischemia; Critical limb-threatening ischemia; Calcified peripheral artery lesions; Vessel preparation; Femoropopliteal arteries; Infrapopliteal arteries; OA; Atherectomy for calcified lesions

Outcome Measures

Primary Outcomes (1)

• Number of lesions with ≤30% residual stenosis after completion of full planned procedure

  Defined as residual stenosis ≤30%, immediately after completion of full planned procedure (OA + any planned adjunctive intervention(s)).

  Immediately after procedure completion

Secondary Outcomes (14)

• Number of lesions with ≤30% residual stenosis after any unplanned endovascular intervention(s)

  Immediately after procedure completion

• Need for unplanned bailout stenting

  Immediately after procedure completion

• Number of participants free from Clinically-Driven Target Lesion Revascularization (CD-TLR)

  12 and 24 months

• CD-TLR-free survival

  Until the end of the follow-up period of 2 years

• Clinical response using Rutherford classification categories

  12 and 24 months

Study Arms (1)

Adult CLTI patients with femoropopliteal or infrapopliteal calcified lesions

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

Device: Stealth 360™ Peripheral Orbital Atherectomy System from Abbott

Interventions

Stealth 360™ Peripheral Orbital Atherectomy System from Abbott 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.

Also known as: Orbital Atherectomy, Orbital Atherectomy System

Adult CLTI patients with femoropopliteal or infrapopliteal calcified lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult CLTI patients with femoropopliteal or infrapopliteal calcified lesions treated with OA using the Stealth 360 Peripheral OA System for vessel preparation prior to any adjunctive endovascular procedure.

You may qualify if:

• Rutherford classification category ≥4;
• Treatment of femoropopliteal or infrapopliteal calcified lesions with OA using the Stealth 360 peripheral OA System;
• Calcification of target lesions must be visible on fluoroscopy or CT-angiography;
• Patients competent and willing to provide informed consent.

You may not qualify if:

• 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.);
• Inadequate inflow (\>30% stenosis) following optimization;
• Insufficient direct outflow (less than 1 run-off vessel);
• Endovascular procedure(s) on the treatment site within 4 weeks before index procedure;
• Patients planned to receive an above ankle amputation of the target limb;
• Patients enrolled in RESCUE (ClinicalTrials.gov ID NCT07270575).

Sponsors & Collaborators

• Cardiovascular and Interventional Radiological Society of Europe: lead
• Abbott: collaborator

Related Publications (2)

• Nordanstig J, Wann-Hansson C, Karlsson J, Lundstrom M, Pettersson M, Morgan MB. Vascular Quality of Life Questionnaire-6 facilitates health-related quality of life assessment in peripheral arterial disease. J Vasc Surg. 2014 Mar;59(3):700-7. doi: 10.1016/j.jvs.2013.08.099. Epub 2013 Dec 15.

  PMID: 24342060 BACKGROUND

• Filippiadis DK, Binkert C, Pellerin O, Hoffmann RT, Krajina A, Pereira PL. Cirse Quality Assurance Document and Standards for Classification of Complications: The Cirse Classification System. Cardiovasc Intervent Radiol. 2017 Aug;40(8):1141-1146. doi: 10.1007/s00270-017-1703-4. Epub 2017 Jun 5.

  PMID: 28584945 BACKGROUND

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Gerd Grözinger, Prof. Dr. med.

  SLK Kliniken Heilbronn GmbH

  STUDY CHAIR

• Marianne Brodmann, Univ.-Prof. Dr. med.

  Medizinische Universität Graz

  STUDY CHAIR

• Raghu Lakshminarayan, Dr

  Hull University Teaching Hospitals NHS Trust

  STUDY CHAIR

• Stefan Müller-Hülsbeck, Prof. Dr. med.

  DIAKO Krankenhaus gGmBH

  STUDY CHAIR

Central Study Contacts

Claire Poulet, PhD

CONTACT

+41 79 385 16 78; oracue@cirse.org

Dhwani S. Korde, PhD

CONTACT

+4367762942469; oracue@cirse.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 8, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: January 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share