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RECRUITING
NCT06828770

Minima Stent System Post- Approval Study (PAS)

Sponsor: Renata Medical

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-05-21

Completion Date

2031-12

Last Updated

2025-10-23

Healthy Volunteers

No

Interventions

DEVICE

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.

Locations (15)

Children's Hospital Los Angeles

Los Angeles, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Washington University

Saint Louis, Michigan, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Dell Children's Medical Center, The University of Texas at Austin

Austin, Texas, United States

Columbia Hospital at Medical City Dallas Hospital

Dallas, Texas, United States

UVA Health Children's Hospital

Charlottesville, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States