Clinical trialNCT06828770RecruitingObservational

Minima Stent System Post- Approval Study (PAS)

SponsorRenata MedicalEnrollment100Aortic CoarctationPulmonary Artery Stenosis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Arash Salavitabar, MD
Nationwide Children's Hospital
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

15 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 21 May 2025
Primary completion: 31 May 2027
Completion: 31 Dec 2031
Last update posted: 23 Oct 2025
Registered enrollment: 100
Registry id: NCT06828770

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.