Status:

RECRUITING

Minima Stent System Post- Approval Study (PAS)

Lead Sponsor:

Renata Medical

Conditions:

Pulmonary Artery Stenosis

Aortic Coarctation

Eligibility:

All Genders

Brief 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 con...

Detailed Description

A minimum of 100 subjects will be enrolled. Follow-up will occur immediately after the initial implant procedure, at subsequent re-dilation procedures, annually, and at any additional standard of care...

Eligibility Criteria

Inclusion Criteria:

  • The subject's legally authorized representative has been informed of the nature of the device treatment, agrees to its provisions, and has provided written informed consent
  • Indicated for treatment with the Minima Stent System per the IFU.

Exclusion Criteria:

  • Active bloodstream infection requiring antibiotic therapy within 3 days prior to stent implantation
  • History of or active endocarditis (active treatment with antibiotics) within 180 days prior to stent implantation
  • Aortic or pulmonary artery aneurysm in the location targeted for treatment
  • Body weight < 1.5 kg
  • Anatomic location of lesion judged by the investigator to not lend to the safe placement of a stent
  • Target vessels larger or smaller than the Minima System balloon size ranges
  • Known genetic syndrome known to be associated with vasculopathies such as but not limited to Williams syndrome, Loeys-Dietz syndrome, etc
  • Clinical scenario requiring that more than one vessel needs stent implantation at the time of the trial procedure.
  • Currently participating in an investigational drug study or another device study
  • Major or progressive non-cardiac disease resulting in a life expectancy of less than six months
  • Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
  • Known hypersensitivity to cobalt-chromium or contrast media that cannot be adequately premedicated

Key Trial Info

Start Date :

May 21 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2031

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06828770

Start Date

May 21 2025

End Date

December 1 2031

Last Update

October 23 2025

Active Locations (15)

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Page 1 of 4 (15 locations)

1

Children's Hospital Los Angeles

Los Angeles, California, United States, 90027

2

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

3

Nicklaus Children's Hospital

Miami, Florida, United States, 33155

4

Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30329