Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07270562 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: ORACLE
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 5 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 2026 to Aug 31, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 4 of 14 entries
    • Publications: details revised at 2 of 2 entries
  2. Start date: Apr 2026 to Aug 2026
    • Primary completion pushed from Apr 2031 to Aug 2031
    v3
  3. Primary endpoint revised
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints revised (14)
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07270562
Lead Sponsor Cardiovascular and Interventional Radiological Society of Europe
Collaborators: Abbott
Conditions
(from sponsor)		 Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
Related terms Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov