Minima Stent System Post- Approval Study (PAS)
Start Date
5/21/2025
Completion Date
12/1/2031
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.
Detailed Description
A minimum of 100 subjects will be enrolled. Follow-up will occur immediately after the initial implant procedure, at subsequent re-dilation procedures, annually, and at any additional standard of care follow-up visits (determined by the implanting physician) through 5 years post-implant. Data collected at each follow-up will be used in analysis. This study will monitor key data points related to the device and procedure.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Minima Stent System
Conditions
Locations
Children's Hospital Los Angeles
Los Angeles, California 90027
United States
Children's Hospital Colorado
Aurora, Colorado 80045
United States
Nicklaus Children's Hospital
Miami, Florida 33155
United States
Children's Healthcare of Atlanta
Atlanta, Georgia 30329
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana 46202
United States
Boston Children's Hospital
Boston, Massachusetts 02115
United States
Washington University
Saint Louis, Michigan 63130
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
Nationwide Children's Hospital
Columbus, Ohio 43205
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
United States
Dell Children's Medical Center, The University of Texas at Austin
Austin, Texas 78723
United States
Columbia Hospital at Medical City Dallas Hospital
Dallas, Texas 75230
United States
UVA Health Children's Hospital
Charlottesville, Virginia 22903
United States
Seattle Children's Hospital
Seattle, Washington 98105
United States