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Growth Trial: Study of the Renata Minima Stent

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Results first posted: Mar 25, 2025
    • Primary endpoints revised (2)
    • Secondary endpoints revised (6)
    v6
  2. Primary completion date changed from estimate of Mar 30, 2024 to Feb 26, 2024
    • Secondary endpoints: 2 to 6
    v5
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 2023 to Mar 30, 2024
    • Study completion date: Jun 2028 to Mar 30, 2028
    • Site details revised at 7 of 7 sites
    v4
  4. Enrollment target: 10 to 42v3 Show 7 more changesShow less
    • Primary completion date: Jun 2022 to Dec 2023
    • Primary endpoints: 3 to 2
    • Study sites: 4 to 7
    • Study completion date: Jun 2027 to Jun 2028
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: 4 to 2
    • Study arms: 0 to 1
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Dec 2021 to Jan 14, 2021
    • Study title shortened, about 1 word
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 objective of the clinical investigation is to access clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e., coarctation of the aorta and/or pulmonary artery stenosis) who are indicated for treatment.
Trial Details
NCT Number NCT05086016
Lead Sponsor Renata Medical
Conditions
(from sponsor)		 Coarctation of the Aorta, Pulmonary Artery Stenosis
Related terms Aortic Coarctation, Stenosis, Pulmonary Artery
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov