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Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis

StatusRecruiting
PhaseNot specified
Started
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Record History

  1. Study description revised Study title shortened, about 1 wordv2 Show 1 more changeShow less
    • Study title shortened, about 1 word

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  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this observational study is to evaluate the long-term effectiveness and safety of the OSFIT drug-eluting stent designed to facilitate procedures in coronary artery lesions. Additionally, the study aims to verify the accuracy of stent placement in the lesion of interest using Optical Coherence Tomography (OCT) among subgroups of participants. The primary endpoint was defined as the composite of target lesion failure (TLF) at the 12-month mark, including cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization.
Trial Details
NCT Number NCT06066450
Lead Sponsor Genoss Co., Ltd.
Conditions Drug-eluting Stent, Coronary Artery Disease
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov