Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorStarlight Cardiovascular Inc
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Active blood stream infection
Active or history of endocarditis
Body weight <2.5kg
Gestational age <32 weeks at birth
Trial design
Treatments tested in this trial
- Ductus Arteriosus Stent
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Starlight Cardiovascular Inc
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov