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PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients

Study acronym: PARIS
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting Site details revised at 19 of 19 sitesv21 Show 1 more changeShow less
    • Site details revised at 19 of 19 sites
  2. Study sites: 18 to 19v20
  3. Primary completion date: Jan 30, 2026 to Dec 30, 2026 Study sites: 17 to 18v19 Show 1 more changeShow less
    • Study sites: 17 to 18
  4. Study sites: 16 to 17 Primary completion date: Sep 30, 2025 to Jan 30, 2026v18 Show 1 more changeShow less
    • Primary completion date: Sep 30, 2025 to Jan 30, 2026
  5. Study sites: 15 to 16v17
Show 15 earlier versionsHide 15 earlier versions
  1. Study sites: 14 to 15v16
  2. Study sites: 12 to 14v15
  3. Re-verified, no change to tracked fieldsv14
  4. Study sites: 11 to 12v13
  5. Study sites: 10 to 11v12
  6. Eligibility criteria expanded, about 36 wordsv11 See this version in full on ClinicalTrials.gov ↗
  7. Eligibility criteria expanded, about 7 wordsv10 See this version in full on ClinicalTrials.gov ↗
  8. Study sites: 9 to 10v9
  9. Study sites: 8 to 9v8
  10. Study sites: 7 to 8v7
  11. Study sites: 5 to 7v6
  12. Re-verified, no change to tracked fieldsv5
  13. Study sites: 4 to 5v4
  14. Study sites: 2 to 4v3
  15. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Mar 28, 2024 to Feb 26, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Mar 28, 2024 to Feb 26, 2024
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Post-market, prospective, observational, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon (DCB)therapy in real-world patients with small native vessel coronary artery disease, and to demonstrate the safety of short dual antiplatelet therapy (7 days) in high-bleeding risk patients with native small vessel coronary artery disease treated with DCB therapy. A percutaneous coronary intervention (PCI) with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician.
Trial Details
NCT Number NCT06321757
Lead Sponsor Fundación EPIC
Conditions Coronary Artery Disease
Enrollment 501 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov