Post-Approval Study of the Renata Minima Stent in the Treatment of Vascular Stenoses in Neonates, Infants, and Small Children
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Children's Hospital Los Angeles
RECRUITING
Los Angeles
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Florida
Nicklaus Children's Hospital
RECRUITING
Miami
Georgia
Children's Healthcare of Atlanta
RECRUITING
Atlanta
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Indiana
Riley Hospital for Children at Indiana University Health
RECRUITING
Indianapolis
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Michigan
Washington University
RECRUITING
Saint Louis
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Nationwide Children's Hospital
RECRUITING
Columbus
Pennsylvania
UPMC Children's Hospital of Pittsburgh
RECRUITING
Pittsburgh
Texas
Dell Children's Medical Center, The University of Texas at Austin
RECRUITING
Austin
Columbia Hospital at Medical City Dallas Hospital
RECRUITING
Dallas
Virginia
UVA Health Children's Hospital
RECRUITING
Charlottesville
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Contact Information
Primary
Renata Medical Clinical & Regulatory Affairs
dali@renatamedical.com
855-318-4988
Backup
Renata Medical Corporate
949-478-0539
Time Frame
Start Date: 2025-05-21
Estimated Completion Date: 2031-12
Participants
Target number of participants: 100
Treatments
Minima PAS Patients
Those treated with the Renata Minima Stent System
Related Therapeutic Areas
Sponsors
Leads: Renata Medical