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Intracoronary Stenting and Restenosis - Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5

Study acronym: ISAR-DESIRE5
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 6, 2025 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study sites: 4 to 5v5
  2. Study sites: 3 to 4v4
  3. Study sites: 1 to 3
    • Eligibility criteria expanded, about 10 words
    • Collaborators revised (3)
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2022 to Sep 28, 2022
    • Site details revised
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The hypothesis of the study is, that there is a significant interaction in treatment effect between the OCT pattern of neointima (heterogeneous or homogeneous) and the type of percutaneous coronary intervention (drug-eluting stent or drug-coated balloon) in patients with in-stent restenosis.
Trial Details
NCT Number NCT05544864
Lead Sponsor Deutsches Herzzentrum Muenchen
Collaborators: EvidentIQ Germany GmbH, Abbott, Technical University of Munich
Conditions
(from sponsor)		 Coronary Artery Disease, Restenoses, Coronary
Related terms Coronary Artery Disease, Coronary Restenosis
Enrollment 376 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov