Ductus Arteriosus Stent: The eligible subjects will proceed to implantation of the Lifeline Ductus Arteriosus Stent to maintain patency of the PDA.
Study 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.
Eligibility
Sex
ALL
Min age
1 Minute
Max age
6 Months
Healthy volunteers
No
Inclusion Criteria:
1. Parental or legal authorized representative provide consent for study enrollment
2. Infants \< 6 months of age
3. Diagnosis of congenital heart defect with ductal-dependent pulmonary circulation requiring infusion of prostaglandins
4. Requires ductus arteriosus stent diameters of 3.5mm or 4mm and stent lengths between 16mm and 28mm
Exclusion Criteria:
1. Active blood stream infection
2. Active or history of endocarditis
3. Body weight \<2.5kg
4. Gestational age \<32 weeks at birth
5. Complete heart block
6. Total Anomalous Pulmonary Venous Return
7. Anatomic variation judged to be inappropriate for ductal stenting per the treating interventionalist
8. Presence of an aortopulmonary collateral that is expected to require unifocalization
9. Non-confluent pulmonary arteries (i.e. isolated pulmonary artery of ductal origin) or bilateral patent ductus arteriosus (PDA)
10. Pulmonary atresia with intact ventricular septum with RV-dependent coronary circulation
11. Currently participating in an investigational drug study or another device study that would confound the study results
12. Patient who is on extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), or dialysis prior to ductal stenting procedure
13. Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.)
14. 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
15. 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
16. 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
17. Contraindications to peri-procedural anticoagulation
18. Known to be non-responsive to aspirin or other antiplatelet therapies
19. Known hypersensitivity or allergy to Nickel
20. Known hypersensitivity to contrast media that cannot be adequately pre-medicated
Primary outcome measure(s)
Primary Safety Endpoint — Implant to 30 days Freedom from death related to the device or implantation procedure or Major Complication related to the device or implantation procedure at 30 days.
Primary Efficacy Endpoint — Implant to 180 days 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.
Trial sites (10)
Facility
City
Region
Status
UCLA Mattel Children's
Los Angeles
California
Recruiting
Rady Children's Hospital San Diego
San Diego
California
Not Yet Recruiting
Leland Stanford Junior University
Stanford
California
Recruiting
Children's Hospital Colorado
Aurora
Colorado
Recruiting
Boston Children's Hospital
Boston
Massachusetts
Not Yet Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati
Ohio
Recruiting
Nationwide Children's Hospital
Columbus
Ohio
Recruiting
Children's Hospital of Philadelphia
Philadelphia
Pennsylvania
Recruiting
Texas Children's Hospital - Baylor College of Medicine
Houston
Texas
Recruiting
Seattle Children's Hospital
Seattle
Washington
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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