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Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation

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

Record History

  1. Minor Study sites: 12 to 13v12
  2. Minor Study sites: 11 to 12v11
  3. Minor Study sites: 10 to 11v10
  4. Minor Study sites: 9 to 10v9
  5. Minor Study sites: 8 to 9v8
Show 6 earlier versionsHide 6 earlier versions
  1. Minor Study sites: 7 to 8v7
  2. Minor Study sites: 6 to 7v6
  3. Minor Study sites: 5 to 6v5
  4. Minor Study sites: 4 to 5v4
  5. Minor Study sites: 3 to 4v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Mar 31, 2025 to May 6, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Mar 31, 2025 to May 6, 2025
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding. The new generation of ultrathin strut sirolimus-eluting stent with bioabsorbable polymer allow for shorter antiplatelets regimens and could be a good option for this high-bleeding risk patients.
Trial Details
NCT Number NCT06863155
Lead Sponsor Fundación EPIC
Conditions Coronary Artery Disease, Ischemic Heart Disease
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov