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DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.

Study acronym: DEBSCAN-IVL
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 14 to 15 Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 1 of 28 entries · Publications: 7 to 8 Show 3 more changesShow less
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 28 entries
    • Publications: 7 to 8
  2. Study sites: 13 to 14v17
  3. Study sites: 12 to 13v16
  4. Study sites: 11 to 12v15
  5. Re-verified, no change to tracked fieldsv14
Show 12 earlier versionsHide 12 earlier versions
  1. Study sites: 9 to 11 Secondary endpoints: details revised at 5 of 28 entries · Eligibility criteria shortened, about 1 wordv13 Show 2 more changesShow less
    • Secondary endpoints: details revised at 5 of 28 entries
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 8 to 9v12
  3. Study sites: 7 to 8v11
  4. Study sites: 6 to 7v10
  5. Study sites: 5 to 6v9
  6. Study sites: 4 to 5v8
  7. Study sites: 3 to 4v7
  8. Study sites: 2 to 3v6
  9. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 31, 2024 to Dec 17, 2024 · Site details revised at 2 of 2 sitesv5 Show 2 more changesShow less
    • Start date changed from estimate of Dec 31, 2024 to Dec 17, 2024
    • Site details revised at 2 of 2 sites
  10. Study sites: 1 to 2v4
  11. Study sites: 0 to 1v3
  12. Start date: Oct 30, 2024 to Dec 31, 2024v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
International, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo lesions due to calcified nodules (CN) were randomized to drug eluting balloon (DEB) or drug eluting stents (DES).
Trial Details
NCT Number NCT06657833
Lead Sponsor Fundación EPIC
Conditions Coronary Artery Disease
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov