Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
{ "Starlight Cardiovascular Lifeline Ductus Arteriosus Stent Study for Congenital Heart Disease", "This study is testing a device called the Lifeline Ductus Arteriosus Stent. This stent is designed to keep open a blood vessel in the heart called the ductus arteriosus, which is important for babies with certain congenital heart defects (heart problems present at birth). The study aims to see if the stent is safe and effective for these babies. You might be able to join if your baby is under 6 months old, has a congenital heart defect that relies on this blood vessel for blood flow, and needs a stent of a specific size. The study is looking for 35 participants and its current recruitment status is unclear.", "design": "This is an interventional study, meaning participants will receive the Lifeline Ductus Arterius Stent. It plans to enroll 35 participants.", "commitments": "Eligible subjects will have the Lifeline Ductus Arteriosus Stent implanted. Safety will be measured from implant to 30 days, and effectiveness from implant to 180 days.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for safety from the time of stent implantation up to 30 days, and for effectiveness up to 180 days after implantation.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
At a glance
Conditions
NCT07114718
Where you'd take part
This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Boston Children's Hospital
Boston, Massachusettsstudy coordinator listed
Not yet recruiting
Children's Hospital Colorado
Aurora, Coloradostudy coordinator listed
Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohiostudy coordinator listed
Recruiting
Leland Stanford Junior University
Stanford, Californiastudy coordinator listed
Recruiting
Nationwide Children's Hospital
Columbus, Ohiostudy coordinator listed
Recruiting
Rady Children's Hospital San Diego
San Diego, Californiastudy coordinator listed
Not yet recruiting
Seattle Children's Hospital
Seattle, Washingtonstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Primary Safety EndpointImplant 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 EndpointImplant 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.