Minima Stent System Post- Approval Study (PAS)

NCT06828770 · tracked via the Priya Life Science USA tracker

Sponsor

Renata Medical

Phase

Observational

Started

2025-05-21

Last updated

2025-10-23

Condition(s) studied

Pulmonary Artery StenosisAortic Coarctation

Investigational drug(s) / intervention(s)

Minima Stent System

Minima Stent System: Minima Stent System is indicated for use in the treatment of native or acquired pulmonary artery stenoses or coarctation of the aorta in neonates, infants, and children at least 1.5kg in weight.

Study 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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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 outcome measure(s)

Rate of Acute Device Success — End of Procedure (Following Implantation of the Stent)
Rate of Acute device success as defined by: * Stenosis relief, defined by stent outer diameter ≥ 75% of the normal surrounding vessel immediately after deployment. * Freedom from open surgical intervention required to treat Minima Stent dysfunction at implantation
Rate of Participants with Freedom from procedure- or device-related SAEs — Immediately after Postoperative
Rate of Participants with Freedom from procedure- or device-related SAEs resulting in an event listed below: * Death * Cardiac arrest and/or emergency ECMO cannulation * Stroke * Limb loss * Vessel dissection of target lesion * Device thrombosis/occlusion * Cardiac perforation requiring percutaneous or open surgical intervention * Persistent cardiac arrhythmia requiring a pacemaker

Trial sites (15)

Facility	City	Region	Status
Children's Hospital Los Angeles	Los Angeles	California	Recruiting
Children's Hospital Colorado	Aurora	Colorado	Recruiting
Nicklaus Children's Hospital	Miami	Florida	Recruiting
Children's Healthcare of Atlanta	Atlanta	Georgia	Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	Recruiting
Riley Hospital for Children at Indiana University Health	Indianapolis	Indiana	Recruiting
Boston Children's Hospital	Boston	Massachusetts	Recruiting
Washington University	Saint Louis	Michigan	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	Recruiting
Nationwide Children's Hospital	Columbus	Ohio	Recruiting
UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	Recruiting
Dell Children's Medical Center, The University of Texas at Austin	Austin	Texas	Recruiting
Columbia Hospital at Medical City Dallas Hospital	Dallas	Texas	Recruiting
UVA Health Children's Hospital	Charlottesville	Virginia	Recruiting
Seattle Children's Hospital	Seattle	Washington	Recruiting

More Renata Medical trials in the USA

Growth Trial: Study of the Renata Minima Stent Active, not recruiting

Other trials for the same condition

Growth Trial: Study of the Renata Minima Stent Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06828770 on ClinicalTrials.gov ↗ ← All trials in the USA