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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
The eligible subjects will proceed to implantation of the Lifeline Ductus Arteriosus Stent to maintain patency of the PDA.
UCLA Mattel Children's
Los Angeles, California, United States
RECRUITINGRady Children's Hospital San Diego
San Diego, California, United States
NOT_YET_RECRUITINGPrimary Safety Endpoint
Freedom from death related to the device or implantation procedure or Major Complication related to the device or implantation procedure at 30 days.
Time frame: Implant to 30 days
Primary Efficacy Endpoint
Freedom from open surgical intervention to address stent dysfunction in subjects with a Lifeline stent implanted at the earlier of 180 days or the time of stent division or ligation during complete surgical repair or second stage surgery.
Time frame: Implant to 180 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Leland Stanford Junior University
Stanford, California, United States
RECRUITINGChildren's Hospital Colorado
Aurora, Colorado, United States
RECRUITINGBoston Children's Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
RECRUITINGNationwide Children's Hospital
Columbus, Ohio, United States
RECRUITINGChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITINGTexas Children's Hospital - Baylor College of Medicine
Houston, Texas, United States
RECRUITINGSeattle Children's Hospital
Seattle, Washington, United States
RECRUITING