NCT06828770 Minima Stent System Post- Approval Study (PAS)
| NCT ID | NCT06828770 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Renata Medical |
| Condition | Pulmonary Artery Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-05-21 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-05-21 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 continue the assessment of device performance and capture outcome data on use of the device in real-world use.
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
Contact & Investigator
Arash Salavitabar, MD
PRINCIPAL INVESTIGATOR
Nationwide Children's Hospital
Frequently Asked Questions
Who can join the NCT06828770 clinical trial?
This trial is open to participants of all sexes, studying Pulmonary Artery Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06828770 currently recruiting?
Yes, NCT06828770 is actively recruiting participants. Contact the research team at dali@renatamedical.com for enrollment information.
Where is the NCT06828770 trial being conducted?
This trial is being conducted at Los Angeles, United States, Aurora, United States, Miami, United States, Atlanta, United States and 11 additional locations.
Who is sponsoring the NCT06828770 clinical trial?
NCT06828770 is sponsored by Renata Medical. The principal investigator is Arash Salavitabar, MD at Nationwide Children's Hospital. The trial plans to enroll 100 participants.