RecruitingNot Applicable

Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study

United States35 participantsStarted 2026-01-16

Plain-language 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.

Who can participate

Age range1 Minute – 6 Months

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Primary Safety Endpoint

Timeframe: Implant to 30 days

Primary Efficacy Endpoint

Timeframe: Implant to 180 days

Trial details

NCT IDNCT07114718

SponsorStarlight Cardiovascular Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Mary Beth Tate, BSBE-MBA

734-709-2080 marybeth.tate@globalmedicaldeviceconsultants.com

View on ClinicalTrials.gov More Congenital Heart Disease trials