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Transfemoral Implant of Inovare® Transcatheter Valve

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 11, 2024 (before its estimated February 20, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Aug 30, 2023 to Feb 20, 2024
    • Study completion date: Dec 30, 2027 to Dec 30, 2028
    • Site details revised at 4 of 4 sites
    v3
  2. Primary completion date: Jan 30, 2023 to Aug 30, 2023v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Clinical trial to evaluate the early safety and efficacy of the transfemoral implant of Inovare® Transcatheter Valve for the treatment of patients with severe degenerative aortic stenosis and high surgical risk.
Trial Details
NCT Number NCT05531578
Lead Sponsor Braile Biomedica Ind. Com. e Repr. Ltda.
Conditions
(from sponsor)		 Aortic Valve Stenosis
Related terms Aortic Valve Stenosis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov