Lifeline ductus arteriosus stent for infants with ductal-dependent circulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Starlight Cardiovascular is sponsoring a prospective, multicenter trial to test the safety and effectiveness of the Lifeline Ductus Arteriosus Stent System in infants with ductal-dependent pulmonary circulation. Infants under 6 months who require prostaglandin infusion and meet device size criteria will have the stent placed percutaneously and be followed for clinical outcomes. The study will collect safety and effectiveness endpoints across several pediatric cardiac centers to support a potential FDA approval. Patients with certain anatomic variations, active infections, very low birth weight, or other exclusion criteria will not be enrolled.

Why it matters

Who can join: the full rules

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

Where it's running

• UCLA Mattel Children's
  Los Angeles, California, United States Recruiting
• Rady Children's Hospital San Diego
  San Diego, California, United States Recruiting
• Leland Stanford Junior University
  Stanford, California, United States Recruiting
• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: Mary Beth Tate, BSBE-MBA
• Email: marybeth.tate@globalmedicaldeviceconsultants.com
• Phone: 734-709-2080

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.