Congenital Heart DiseaseNCT07114718
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
A study testing Ductus Arteriosus Stent in people with Congenital Heart Disease and Congenital Heart Disease (CHD), run by Starlight Cardiovascular Inc at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 6 months
- Conditions the study is for
- Congenital Heart Disease, Congenital Heart Disease (CHD)
- What is being tested?
- Ductus Arteriosus Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 11 sitesUnited States
- Study dates
- 16 Jan 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
- Patient who does not plan to return to the enrolling center or another participating center for stage II palliation, complete surgical repair, or definitive catheterization procedure
- Contraindications to peri-procedural anticoagulation
- Known to be non-responsive to aspirin or other antiplatelet therapies
- Known hypersensitivity or allergy to Nickel
- Known hypersensitivity to contrast media that cannot be adequately pre-medicated
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Maria Dornon, maria.dornon@childrenscolorado.org
Jenny Zablah, MD
- Not yet recruiting
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
Kate Kalligy, 443-297-9595, lcummi15@jhmi.edu
Aimee Armstrong, MD
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Lizzy Cooney, 6179195257, lizzie.cooney@childrens.harvard.edu
Diego Porras, MD
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Amy Pajk, 5138030380, amy.pajk@cchmc.org
Shabana Shahanavaz, MD
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Victoria Shay, 6143555819, victoria.shay@nationwidechildrens.org
Aimee Armstrong, MD
- Recruiting
Texas Children's Hospital - Baylor College of Medicine
Houston, Texas, 77030
Lesley Cruz, 832-826-5925, lxcruz@texaschildrens.org
Athar Qureshi, MD
- Recruiting
UCLA Mattel Children's
Los Angeles, California, 90095
Nicholas Sharaway, 3102677600, nsharaway28@g.ucla.edu
Sanjay Sinha, MD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Olivia Martino, 215-590-1000, martinoo@chop.edu
Matthew Gillespie, MD
- Recruiting
Rady Children's Hospital San Diego
San Diego, California, 92123
Yu Xiaoyang, 858-576-1700 ext. 22100
Howaida El-Said, MD
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Jeremy Gillis, 2069876580, Jeremy.gillis@seattlechildrens.org
Brian Morray, MD
- Recruiting
Leland Stanford Junior University
Stanford, California, 94305
Kifle Yohannes, 6507244661, kifley@stanford.edu
Doff McElhinney, MD
About this study
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.
Read the detailed description
Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the LifelineTM Ductus Arteriosus Stent System.
The purpose of the study is to determine whether the Ductus Arteriosus Stent System demonstrates safety and effectiveness for patients who require ductal patency and merits Food and Drug Administration (FDA) approval.
- Being tested
- Ductus Arteriosus Stent
- Keywords
- Ductus Arteriosus Stent, pediatric stent, Lifeline Stent
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ductus Arteriosus StentDevice
Also called Stent, Pediatric Stent
The eligible subjects will proceed to implantation of the Lifeline Ductus Arteriosus Stent to maintain patency of the PDA.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm - Treatment | Other | Treatment with the Lifeline Ductus Arteriosus Stent Receives: Device: Ductus Arteriosus Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Implant to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start16 Jan 2026
- Primary completionOct 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Starlight Cardiovascular Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114718
- Sponsor's protocol ID
- G250132
- Other IDs
- 2R44HL158304-04A1
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
- ClinicalTrials.gov ID
- NCT07114718
- Acronym / sponsor ID
- G250132
- Keywords
- Ductus Arteriosus Stent, pediatric stent, Lifeline Stent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Starlight Cardiovascular IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the LifelineTM Ductus Arteriosus Stent System.
The purpose of the study is to determine whether the Ductus Arteriosus Stent System demonstrates safety and effectiveness for patients who require ductal patency and merits Food and Drug Administration (FDA) approval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm - Treatment | Other | Device: Ductus Arteriosus StentTreatment with the Lifeline Ductus Arteriosus Stent |
Who may qualify
- Ages
- 1 minute to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- Active blood stream infection
- Active or history of endocarditis
- Body weight <2.5kg
- Gestational age <32 weeks at birth
- Complete heart block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ductus Arteriosus StentAlso: Stent, Pediatric StentThe eligible subjects will proceed to implantation of the Lifeline Ductus Arteriosus Stent to maintain patency of the PDA. | Device | Single Arm - Treatment |
Primary outcome
Primary Safety Endpoint
Time frame: Implant to 30 days
Freedom from death related to the device or implantation procedure or Major Complication related to the device or implantation procedure at 30 days.
Primary Efficacy Endpoint
Time frame: Implant to 180 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ductus Arteriosus Stent in people with Congenital Heart Disease and Congenital Heart Disease (CHD), run by Starlight Cardiovascular Inc at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Beth Tate, BSBE-MBA (734-709-2080, marybeth.tate@globalmedicaldeviceconsultants.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: Implant to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.