Clinical trial NCT06828770: Minima Stent System Post- Approval Study (PAS)
Official title: Post-Approval Study of the Renata Minima Stent in the Treatment of Vascular Stenoses in Neonates, Infants, and Small Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pulmonary Artery Stenosis
Aortic Coarctation
Keywords: Vascular Stenosis
Minima
Minima Stent
Minima Stent System
Renata Medical
Renata
infant stent
Lead sponsor: Renata Medical
Sponsor class: INDUSTRY
First posted: 2025-02-14
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with the Renata Minima Stent System in the United States

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.

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 follow-up visits (determined by the implanting physician) through 5 years post-implant. Data collected at each follow-up will be used in analysis. This study will monitor key data points related to the device and procedure.

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

Primary outcomes:
measure: Rate of Acute Device Success
timeFrame: End of Procedure (Following Implantation of the Stent)
measure: Rate of Participants with Freedom from procedure- or device-related SAEs
timeFrame: Immediately after Postoperative
Secondary outcomes:
measure: Rate of Successful Stent Re-Dilation and Peak-to-Peak Pressure gradient
timeFrame: During and end of procedure
measure: Rate of Participants with Freedom from Stent Migration/Embolization, procedure- or device- related SAEs, and non-elective stent explant
timeFrame: During and at end of procedure
Other outcomes:
Locations:
Study officials:
affiliation: Nationwide Children's Hospital
name: Arash Salavitabar, MD
role: PRINCIPAL_INVESTIGATOR
References: