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Minima Stent System Post- Approval Study (PAS)

RecruitingObservational study

Post-Approval Study of the Renata Minima Stent in the Treatment of Vascular Stenoses in Neonates, Infants, and Small Children

Who can join

All ages · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: Renata Medical · Participants: 100 · Started: May 21, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06828770

Locations in the U.S.

CaliforniaChildren's Hospital Los Angeles, Los Angeles
ColoradoChildren's Hospital Colorado, Aurora
FloridaNicklaus Children's Hospital, Miami
GeorgiaChildren's Healthcare of Atlanta, Atlanta
IllinoisAnn & Robert H. Lurie Children's Hospital of Chicago, Chicago
IndianaRiley Hospital for Children at Indiana University Health, Indianapolis
MassachusettsBoston Children's Hospital, Boston
MichiganWashington University, Saint Louis
OhioCincinnati Children's Hospital Medical Center, Cincinnati
Nationwide Children's Hospital, Columbus
PennsylvaniaUPMC Children's Hospital of Pittsburgh, Pittsburgh
TexasDell Children's Medical Center, The University of Texas at Austin, Austin
Columbia Hospital at Medical City Dallas Hospital, Dallas
VirginiaUVA Health Children's Hospital, Charlottesville
WashingtonSeattle Children's Hospital, Seattle

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.