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Clinical Trials in the USA / NCT06828770
Recruiting Observational

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
No
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)

FacilityCityRegionStatus
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

Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis Recruiting
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