Actively Recruiting
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Led by Starlight Cardiovascular Inc · Updated on 2026-05-01
35
Participants Needed
8
Research Sites
115 weeks
Total Duration
On this page
Sponsors
S
Starlight Cardiovascular Inc
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parental or legal authorized representative provides consent for study enrollment
- Infant younger than 6 months of age
- Diagnosis of congenital heart defect with ductal-dependent pulmonary circulation requiring prostaglandin infusion
- Requires ductus arteriosus stent diameters of 3.5mm or 4mm and stent lengths between 16mm and 28mm
You will not qualify if you...
- Active bloodstream infection
- Active or history of endocarditis
- Body weight less than 2.5 kg
- Gestational age less than 32 weeks at birth
- Complete heart block
- Total Anomalous Pulmonary Venous Return
- Anatomic variation inappropriate for ductal stenting per treating interventionalist
- Presence of an aortopulmonary collateral expected to require unifocalization
- Non-confluent pulmonary arteries or bilateral patent ductus arteriosus
- Pulmonary atresia with intact ventricular septum with RV-dependent coronary circulation
- Participating in another investigational drug or device study that could affect results
- Receiving extracorporeal membrane oxygenation, ventricular assist device, or dialysis before stenting
- Major co-morbidities negatively affecting expected 1-year survival
- Undergoing another transcatheter procedure during or within 24 hours prior to stenting
- Not a candidate for eventual stage II palliation, surgical repair, or transcatheter treatment with biventricular circulation
- Does not plan to return for stage II palliation, surgical repair, or definitive catheterization
- Contraindications to peri-procedural anticoagulation
- Known non-response to aspirin or other antiplatelet therapies
- Known allergy to nickel
- Known hypersensitivity to contrast media that cannot be pre-medicated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
UCLA Mattel Children's
Los Angeles, California, United States, 90095
Actively Recruiting
2
Leland Stanford Junior University
Stanford, California, United States, 94305
Actively Recruiting
3
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
5
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
6
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
7
Texas Children's Hospital - Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
8
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
M
Mary Beth Tate, BSBE-MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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