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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Ductus Arteriosus Stent
DeviceThe eligible subjects will proceed to implantation of the Lifeline Ductus Arteriosus Stent to maintain patency of the PDA.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Single Arm - TreatmentOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Implant to 30 days2
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.
Time frame
Implant to 180 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Starlight Cardiovascular Inc
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov