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

NCT07270562 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2026-01-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Cardiovascular and Interventional Radiological Society of Europe

    lead OTHER

Principal Investigators

  • Gerd Grözinger, Prof. Dr. med. · SLK Kliniken Heilbronn GmbH

  • Marianne Brodmann, Univ.-Prof. Dr. med. · Medizinische Universität Graz

  • Raghu Lakshminarayan, Dr · Hull University Teaching Hospitals NHS Trust

  • Stefan Müller-Hülsbeck, Prof. Dr. med. · DIAKO Krankenhaus gGmBH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2031-04-30
Completion
2031-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07270562 on ClinicalTrials.gov