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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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