Follow-up of patients treated with the Minima Stent System
Post-Approval Study of the Renata Minima Stent in the Treatment of Vascular Stenoses in Neonates, Infants, and Small Children
This project will follow people with pulmonary artery stenosis or aortic coarctation who receive the Renata Minima stent to see if the device works well and is safe over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Renata Medical Industry-sponsored |
| Locations | 15 sites (Los Angeles, California and 14 other locations) |
| Trial ID | NCT06828770 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm, multi-center, open-label post-approval registry of at least 100 subjects treated with the Renata Minima Stent System in the United States. Participants are followed immediately after implantation, at any re-dilation procedures, annually, and at other standard-of-care visits determined by the treating physician through 5 years post-implant. Clinical and device-related data points will be captured at each visit to monitor device performance, durability, and procedural outcomes. The study aims to reflect real-world use across pediatric cardiac centers and inform long-term safety and effectiveness.
Who should consider this trial
Good fit: Ideal candidates are patients indicated for treatment with the Minima Stent System per the device instructions for use—typically those with pulmonary artery stenosis or aortic coarctation whose vessel size and anatomy fit the device and who meet weight and infection-free criteria.
Not a fit: Patients unlikely to benefit include those with target-site aneurysms, vessel sizes outside the device balloon ranges, active bloodstream infection or recent endocarditis, known vasculopathy syndromes, body weight under 1.5 kg, or clinical scenarios requiring stenting of more than one vessel.
Why it matters
Potential benefit: If successful, the results could confirm the Minima stent's safety and durability in real-world practice and support its use to reduce restenosis and the need for repeat interventions.
How similar studies have performed: Other registries and trials of expandable vascular stents in pediatric and congenital populations have reported promising short- and mid-term safety and performance, but long-term real-world data are still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California and 14 other locations
- Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Nicklaus Children's Hospital — Miami, Florida, United States (Recruiting)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
- Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Washington University — Saint Louis, Michigan, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
- Dell Children's Medical Center, The University of Texas at Austin — Austin, Texas, United States (Recruiting)
- Columbia Hospital at Medical City Dallas Hospital — Dallas, Texas, United States (Recruiting)
- UVA Health Children's Hospital — Charlottesville, Virginia, United States (Recruiting)
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Arash Salavitabar, MD — Nationwide Children's Hospital
- Study coordinator: Renata Medical Clinical & Regulatory Affairs
- Email: dali@renatamedical.com
- Phone: 855-318-4988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.