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Minima Stent System Post- Approval Study (PAS)

NCT06828770 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-10-23

No results posted yet for this study

Summary

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.

Conditions

  • Pulmonary Artery Stenosis
  • Aortic Coarctation

Interventions

DEVICE

Minima Stent System

Minima Stent System is indicated for use in the treatment of native or acquired pulmonary artery stenoses or coarctation of the aorta in neonates, infants, and children at least 1.5kg in weight.

Sponsors & Collaborators

  • Renata Medical

    lead INDUSTRY

Principal Investigators

  • Arash Salavitabar, MD · Nationwide Children's Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-21
Primary Completion
2027-05-31
Completion
2031-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06828770 on ClinicalTrials.gov