Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
2 other identifiers
interventional
35
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2026
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2025
CompletedFirst Posted
Study publicly available on registry
August 11, 2025
CompletedStudy Start
First participant enrolled
January 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
May 1, 2026
April 1, 2026
1.7 years
August 3, 2025
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary 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.
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.
Implant to 180 days
Study Arms (1)
Single Arm - Treatment
OTHERTreatment with the Lifeline Ductus Arteriosus Stent
Interventions
The eligible subjects will proceed to implantation of the Lifeline Ductus Arteriosus Stent to maintain patency of the PDA.
Eligibility Criteria
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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Starlight Cardiovascular Inclead
- National Institutes of Health (NIH)collaborator
Study Sites (8)
UCLA Mattel Children's
Los Angeles, California, 90095, 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
Texas Children's Hospital - Baylor College of Medicine
Houston, Texas, 77030, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2025
First Posted
August 11, 2025
Study Start
January 16, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share