3rd Generation Resorbable Magnesium Scaffolds vs Biodegradable Polymer Stents in NSTE/ACS

StatusWithdrawn
PhaseNot applicable
Started

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Record History

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  1. Withdrawn before enrolling Sponsor's reason: No funding Show 7 more changesShow less
    • Phase changed: Phase 4 → not applicable
    • Enrollment target: estimated 220 to confirmed 0
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Study description revised
    • Site contacts updated at 5 of 7 sites
    • Publications: details revised at 6 of 6 entries
  2. Study sites: 3 to 7
    • Study description revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multicentre, prospective, randomized controlled trial that will investigate the role and performance of the 3rd generation resorbable magnesium scaffolds "DREAMS 3G" labeled under the name "Freesolve" vs contemporary biodegradable polymer scaffolds in non ST-segment elevation acute coronary syndromes. Patients fulfilling the eligibility criteria will be enrolled and undergo PCI with either Freesolve or Orsiro platforms for the culprit lesion only. They will be followed-up for 12 months (1, 6 and 12 months). The primary endopoint will be Target Lesion Failure as defined by ARC definitions.
Trial Details
NCT Number NCT06409117
Lead Sponsor Konstantinos Toutouzas
Collaborators: Centre Hospitalier Universitaire Saint Pierre, Université Catholique de Louvain, University Hospital of Leuven Leuven, University of Patras, Ippokrateio General Hospital of Thessaloniki
Conditions
(from sponsor)		 Acute Coronary Syndrome, Coronary Artery Disease
Related terms Acute Coronary Syndrome, Coronary Artery Disease
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov