Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Recruiting now · Not applicable
Conditions studied: Congenital Heart Disease, Congenital Heart Disease (CHD)
In brief
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.
Key facts
- Study ID
- NCT07114718
- Run by
- Starlight Cardiovascular Inc
- People needed
- 35
- Starts
- 2026-01-16
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2026-05-01
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Parental or legal authorized representative provide consent for study enrollment
- Infants < 6 months of age
- Diagnosis of congenital heart defect with ductal-dependent pulmonary circulation requiring infusion of prostaglandins
- Requires ductus arteriosus stent diameters of 3.5mm or 4mm and stent lengths between 16mm and 28mm
You may not qualify if…
- Active blood stream infection
- Active or history of endocarditis
- Body weight <2.5kg
- Gestational age <32 weeks at birth
- Complete heart block
- Total Anomalous Pulmonary Venous Return
- Anatomic variation judged to be inappropriate for ductal stenting per the treating interventionalist
- Presence of an aortopulmonary collateral that is expected to require unifocalization
- Non-confluent pulmonary arteries (i.e. isolated pulmonary artery of ductal origin) or bilateral patent ductus arteriosus (PDA)
- Pulmonary atresia with intact ventricular septum with RV-dependent coronary circulation
- Currently participating in an investigational drug study or another device study that would confound the study results
- Patient who is on extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), or dialysis prior to ductal stenting procedure
- Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.)
- Patient who is undergoing another transcatheter procedure (e.g., atrial septostomy, aortic arch intervention, or right ventricular outflow tract intervention) during or within 24 hours prior to the ductus arteriosus stenting procedure
- Patient who, at the time of enrollment, is deemed not to be a candidate for eventual stage II palliation of single ventricle heart disease, complete surgical repair, nor transcatheter treatment with resultant biventricular circulation
- Patient who does not plan to return to the enrolling center or another participating center for stage II palliation, complete surgical repair, or definitive catheterization procedure
- Contraindications to peri-procedural anticoagulation
- Known to be non-responsive to aspirin or other antiplatelet therapies
- Known hypersensitivity or allergy to Nickel
- Known hypersensitivity to contrast media that cannot be adequately pre-medicated
Where it is running
- Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
- Leland Stanford Junior University — Stanford, California, United States (enrolling)
- Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
- UCLA Mattel Children's — Los Angeles, California, United States (enrolling)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
- Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
- Texas Children's Hospital - Baylor College of Medicine — Houston, Texas, United States (enrolling)
- Boston Children's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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