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.

NCT07114718

Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study

Recruiting
NAAges 1–6InterventionalTreatment
Starlight Cardiovascular Inc
~45 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:Ductus Arteriosus Stent

At a glance

Recruiting sites
8 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Endpoint
Measured over Implant to 30 days
+1 more outcome measured
Congenital Heart Disease
Congenital Heart Disease (CHD)

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.

Opens a ready-to-send draft in your own email app — review before sending.

  • 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.