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Minima Stent System Post- Approval Study (PAS)

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 15
    • Start date changed from estimate of Mar 2025 to May 21, 2025
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States. The objective of the study is to continue the assessment of device performance and capture outcome data on use of the device in real-world use.
Trial Details
NCT Number NCT06828770
Lead Sponsor Renata Medical
Conditions
(from sponsor)		 Pulmonary Artery Stenosis, Aortic Coarctation
Related terms Aortic Coarctation, Stenosis, Pulmonary Artery
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov