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Coroflex® ISAR NEO PMCF Study

Study acronym: rEPIC07
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites: 25 to 26v19
  2. Minor Study sites: 24 to 25v18
  3. Minor Study sites: 23 to 24v17
  4. Minor Study sites: 22 to 23v16
  5. Minor Study sites: 21 to 22v15
Show 13 earlier versionsHide 13 earlier versions
  1. Minor Study sites: 20 to 21v14
  2. Minor Study sites: 18 to 20v13
  3. Minor Study sites: 12 to 18v12
  4. Minor Eligibility criteria expanded, about 58 wordsv11 See this version in full on ClinicalTrials.gov ↗
  5. Minor Study sites: 11 to 12v10
  6. Minor Study sites: 10 to 11v9
  7. Minor Study sites: 9 to 10v8
  8. Minor Study sites: 8 to 9v7
  9. Minor Study sites: 7 to 8v6
  10. Minor Study sites: 5 to 7v5
  11. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 5 · Start date changed from estimate of Jun 15, 2023 to Aug 4, 2023v4 Show 2 more changesShow less
    • Study sites: 0 to 5
    • Start date changed from estimate of Jun 15, 2023 to Aug 4, 2023
  12. Notable Start date: Apr 15, 2023 to Jun 15, 2023v3
  13. Notable Start date: Feb 1, 2023 to Apr 15, 2023 Study title shortened, about 4 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 4 words

    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.
Trial Details
NCT Number NCT05698732
Lead Sponsor Fundación EPIC
Conditions Coronary Artery Disease (CAD), Ischemic Heart Disease
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov