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Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy

Study acronym: ANGIODAPT
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Study sites: 39 to 38 · Primary completion date: Aug 2026 to Jan 13, 2027 · Completion date: Aug 2030 to Jan 13, 2030v3 Show 3 more changesShow less
    • Study sites: 39 to 38
    • Primary completion date: Aug 2026 to Jan 13, 2027
    • Completion date: Aug 2030 to Jan 13, 2030
  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jul 2025 to Aug 2026 · Study sites: 0 to 39 · Completion date: Jul 2029 to Aug 2030 · 3 morev2 Show 6 more changesShow less
    • Primary completion date: Jul 2025 to Aug 2026
    • Study sites: 0 to 39
    • Completion date: Jul 2029 to Aug 2030
    • Start date changed from estimate of Jul 2023 to Oct 13, 2023
    • Interventions: 1-month DAPT (Drug), 12-month DAPT (Standard of care) (Drug), Angiolite: Sirolimus-eluting stent (Device), Xience: Sirolimus-eluting stent… to 1-month DAPT (Drug), 12-month DAPT (Standard of care) (Drug), Angiolite: Sirolimus-eluting stent (Device), Xience: Everolimus-eluting stent…
    • Eligibility criteria expanded, about 13 words

    See this version in full on ClinicalTrials.gov ↗

  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Factorial 2x2, all-comer, multicentre, randomized controlled trial (ratio 1:1:1:1). First, the study will compare (first randomization) the non-inferiority in target lesion failure of angiolite stent versus Xience stent family. Immediately after the first randomization, the study compares (second randomization) the superiority in bleeding Bleeding Academic Research Consortium (BARC) 2, 3, or 5 of abbreviated DAPT versus standard of care. Both primary endpoints will be evaluated at 12 months of follow-up. The study will be open-label for the stent type and the antiplatelet regimen.
Trial Details
NCT Number NCT05952206
Lead Sponsor iVascular S.L.U.
Conditions Coronary Artery Disease
Enrollment 2,312 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov