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Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

Study acronym: OraBil
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 8 to 9v14
  2. Study sites: 7 to 8v13
  3. Study sites: 6 to 7v12
  4. Study sites: 5 to 6v11
  5. Study sites: 4 to 5v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 3 to 4v9
  2. Primary completion date: Dec 31, 2025 to Dec 31, 2026v8
  3. Study sites: 2 to 3v7
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Oct 1, 2025 to Oct 23, 2025v6 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Oct 1, 2025 to Oct 23, 2025
  5. Start date: May 1, 2025 to Oct 1, 2025v5
  6. Start date: Mar 1, 2025 to May 1, 2025v4
  7. Start date: Jan 1, 2025 to Mar 1, 2025v3
  8. Study title shortened, about 1 wordv2 See this version in full on ClinicalTrials.gov ↗
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Clinical research with medical devices indicated in accordance with the CE marking, led by researchers, multicenter, open, prospective, randomized and controlled. Patients are randomized to treatment with a conventional balloon and then a coronary stent or to initial plaque modification with Orbital Atherectomy (OA) and then a coronary stent. To evaluate the efficacy and safety of OA in the adequate treatment with coronary stent of the calcified bifurcation lesion using angiography and optical coherence tomography (OCT).
Trial Details
NCT Number NCT06736899
Lead Sponsor Fundación EPIC
Conditions Coronary Artery Disease, Coronary Disease
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov