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DRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY) IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY)

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later May 1, 2026 → Dec 1, 2026
See other at-risk trials from Fundación EPIC

Record History

  1. Notable Primary endpoints: details revised at 1 of 1 entry Study sites: 8 to 9 · Eligibility criteria expanded, about 7 words · Publications: details revised at 4 of 5 entries Show 3 more changesShow less
    • Study sites: 8 to 9
    • Eligibility criteria expanded, about 7 words
    • Publications: details revised at 4 of 5 entries
  2. Notable Primary completion pushed from May 1, 2026 to Dec 1, 2026 Completion pushed from May 1, 2027 to Dec 1, 2027 · Study sites: 7 to 8v10 Show 2 more changesShow less
    • Completion pushed from May 1, 2027 to Dec 1, 2027
    • Study sites: 7 to 8
  3. Minor Study sites: 6 to 7v9
  4. Minor Study sites: 5 to 6v8
  5. Minor Study sites: 4 to 5v7
Show 5 earlier versionsHide 5 earlier versions
  1. Minor Study sites: 3 to 4v6
  2. Minor Study sites: 2 to 3v5
  3. Minor Study sites: 1 to 2v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 30, 2024 to Oct 23, 2024 · Study sites: 0 to 1v3 Show 2 more changesShow less
    • Start date changed from estimate of Jun 30, 2024 to Oct 23, 2024
    • Study sites: 0 to 1
  5. Notable Primary endpoint revised Secondary endpoints revised (5)v2 Show 1 more changeShow less
    • Secondary endpoints revised (5)

    See this version in full on ClinicalTrials.gov ↗

  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm
Trial Details
NCT Number NCT06448637
Lead Sponsor Fundación EPIC
Conditions Coronary Artery Disease
Enrollment 94 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov