Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Start Date
1/16/2026
Completion Date
4/1/2028
Summary
Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the Lifeline Ductus Arteriosus Stent System. The study device is a stent that is designed to maintain patency of the Ductus Arteriosus for children who need blood flow through that part of the heart.
Detailed Description
Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the LifelineTM Ductus Arteriosus Stent System. The purpose of the study is to determine whether the Ductus Arteriosus Stent System demonstrates safety and effectiveness for patients who require ductal patency and merits Food and Drug Administration (FDA) approval.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Ductus Arteriosus Stent
Conditions
Locations
UCLA Mattel Children's
Los Angeles, California 90095
United States
Rady Children's Hospital San Diego
San Diego, California 92123
United States
Leland Stanford Junior University
Stanford, California 94305
United States
Children's Hospital Colorado
Aurora, Colorado 80045
United States
Boston Children's Hospital
Boston, Massachusetts 02115
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
Nationwide Children's Hospital
Columbus, Ohio 43205
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Texas Children's Hospital - Baylor College of Medicine
Houston, Texas 77030
United States
Seattle Children's Hospital
Seattle, Washington 98105
United States