[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07114718":3,"trial-entities:NCT07114718":219,"trial-summary:NCT07114718":222},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":40,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":58,"locations":60,"central_contacts":211,"overall_officials":216,"references":217,"see_also_links":218},"NCT07114718","G250132","Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study","RECRUITING","2028-04","2026-09","2026-09-14","2026-01-16","Starlight Cardiovascular Inc","INDUSTRY",true,"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.","Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the LifelineTM Ductus Arteriosus Stent System.\n\nThe 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.",[18,19],"Congenital Heart Disease","Congenital Heart Disease (CHD)",[21,22,23],"Ductus Arteriosus Stent","pediatric stent","Lifeline Stent","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},45,"ESTIMATED",[32],{"type":33,"name":21,"description":34,"armGroupLabels":35,"otherNames":37},"DEVICE","The eligible subjects will proceed to implantation of the Lifeline Ductus Arteriosus Stent to maintain patency of the PDA.",[36],"Single Arm - Treatment",[38,39],"Stent","Pediatric Stent",[41,45],{"measure":42,"description":43,"timeFrame":44},"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.","Implant to 30 days",{"measure":46,"description":47,"timeFrame":48},"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.","Implant to 180 days",[],"ALL","1 Minute","6 Months",false,{"inclusion":55,"exclusion":56,"raw_text":57},[],[],"Inclusion Criteria:\n\n1. Parental or legal authorized representative provide consent for study enrollment\n2. Infants \\\u003C 6 months of age\n3. Diagnosis of congenital heart defect with ductal-dependent pulmonary circulation requiring infusion of prostaglandins\n4. Requires ductus arteriosus stent diameters of 3.5mm or 4mm and stent lengths between 16mm and 28mm\n\nExclusion Criteria:\n\n1. Active blood stream infection\n2. Active or history of endocarditis\n3. Body weight \\\u003C2.5kg\n4. Gestational age \\\u003C32 weeks at birth\n5. Complete heart block\n6. Total Anomalous Pulmonary Venous Return\n7. Anatomic variation judged to be inappropriate for ductal stenting per the treating interventionalist\n8. Presence of an aortopulmonary collateral that is expected to require unifocalization\n9. Non-confluent pulmonary arteries (i.e. isolated pulmonary artery of ductal origin) or bilateral patent ductus arteriosus (PDA)\n10. Pulmonary atresia with intact ventricular septum with RV-dependent coronary circulation\n11. Currently participating in an investigational drug study or another device study that would confound the study results\n12. Patient who is on extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), or dialysis prior to ductal stenting procedure\n13. Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.)\n14. 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\n15. 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\n16. 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\n17. Contraindications to peri-procedural anticoagulation\n18. Known to be non-responsive to aspirin or other antiplatelet therapies\n19. Known hypersensitivity or allergy to Nickel\n20. Known hypersensitivity to contrast media that cannot be adequately pre-medicated",[59],"CHILD",[61,79,94,108,122,137,152,166,181,196],{"facility":62,"status":7,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":76},"UCLA Mattel Children's","Los Angeles","California","90095","United States",[68,73],{"name":69,"role":70,"phone":71,"email":72},"Nicholas Sharaway","CONTACT","310-267-7600","nsharaway28@g.ucla.edu",{"name":74,"role":75},"Sanjay Sinha, MD","PRINCIPAL_INVESTIGATOR",{"lat":77,"lon":78},34.05223,-118.24368,{"facility":80,"status":81,"city":82,"state":64,"zip":83,"country":66,"contacts":84,"geoPoint":91},"Rady Children's Hospital San Diego","NOT_YET_RECRUITING","San Diego","92123",[85,89],{"name":86,"role":70,"phone":87,"phoneExt":88},"Yu Xiaoyang","858-576-1700","22100",{"name":90,"role":75},"Howaida El-Said, MD",{"lat":92,"lon":93},32.71571,-117.16472,{"facility":95,"status":7,"city":96,"state":64,"zip":97,"country":66,"contacts":98,"geoPoint":105},"Leland Stanford Junior University","Stanford","94305",[99,103],{"name":100,"role":70,"phone":101,"email":102},"Kifle Yohannes","650-724-4661","kifley@stanford.edu",{"name":104,"role":75},"Doff McElhinney, MD",{"lat":106,"lon":107},37.42411,-122.16608,{"facility":109,"status":7,"city":110,"state":111,"zip":112,"country":66,"contacts":113,"geoPoint":119},"Children's Hospital Colorado","Aurora","Colorado","80045",[114,117],{"name":115,"role":70,"email":116},"Maria Dornon","maria.dornon@childrenscolorado.org",{"name":118,"role":75},"Jenny Zablah, MD",{"lat":120,"lon":121},39.72943,-104.83192,{"facility":123,"status":81,"city":124,"state":125,"zip":126,"country":66,"contacts":127,"geoPoint":134},"Boston Children's Hospital","Boston","Massachusetts","02115",[128,132],{"name":129,"role":70,"phone":130,"email":131},"Lizzy Cooney","617-919-5257","lizzie.cooney@childrens.harvard.edu",{"name":133,"role":75},"Diego Porras, MD",{"lat":135,"lon":136},42.35843,-71.05977,{"facility":138,"status":7,"city":139,"state":140,"zip":141,"country":66,"contacts":142,"geoPoint":149},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",[143,147],{"name":144,"role":70,"phone":145,"email":146},"Amy Pajk","513-803-0380","amy.pajk@cchmc.org",{"name":148,"role":75},"Shabana Shahanavaz, MD",{"lat":150,"lon":151},39.12711,-84.51439,{"facility":153,"status":7,"city":154,"state":140,"zip":155,"country":66,"contacts":156,"geoPoint":163},"Nationwide Children's Hospital","Columbus","43205",[157,161],{"name":158,"role":70,"phone":159,"email":160},"Victoria Shay","614-355-5819","victoria.shay@nationwidechildrens.org",{"name":162,"role":75},"Aimee Armstrong, MD",{"lat":164,"lon":165},39.96118,-82.99879,{"facility":167,"status":7,"city":168,"state":169,"zip":170,"country":66,"contacts":171,"geoPoint":178},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",[172,176],{"name":173,"role":70,"phone":174,"email":175},"Olivia Martino","215-590-1000","martinoo@chop.edu",{"name":177,"role":75},"Matthew Gillespie, MD",{"lat":179,"lon":180},39.95238,-75.16362,{"facility":182,"status":7,"city":183,"state":184,"zip":185,"country":66,"contacts":186,"geoPoint":193},"Texas Children's Hospital - Baylor College of Medicine","Houston","Texas","77030",[187,191],{"name":188,"role":70,"phone":189,"email":190},"Lesley Cruz","832-826-5925","lxcruz@texaschildrens.org",{"name":192,"role":75},"Athar Qureshi, MD",{"lat":194,"lon":195},29.76328,-95.36327,{"facility":197,"status":7,"city":198,"state":199,"zip":200,"country":66,"contacts":201,"geoPoint":208},"Seattle Children's Hospital","Seattle","Washington","98105",[202,206],{"name":203,"role":70,"phone":204,"email":205},"Jeremy Gillis","206-987-6580","Jeremy.gillis@seattlechildrens.org",{"name":207,"role":75},"Brian Morray, MD",{"lat":209,"lon":210},47.60621,-122.33207,[212],{"name":213,"role":70,"phone":214,"email":215},"Mary Beth Tate, BSBE-MBA","734-709-2080","marybeth.tate@globalmedicaldeviceconsultants.com",[],[],[],{"nct_id":4,"conditions":220,"biomarkers":221},[18],[],{"nct_id":4,"found":14,"summary":223,"prompt_version":231},{"design":224,"status":225,"heading":6,"summary":226,"follow_up":224,"word_count":227,"commitments":228,"compensation":229,"drugs_mentioned":230},"Not specified.","completed","{\n   \"Starlight Cardiovascular Lifeline Ductus Arteriosus Stent Study for Congenital Heart Disease\",\n   \"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.\",\n  \"design\": \"This is an interventional study, meaning participants will receive the Lifeline Ductus Arterius Stent. It plans to enroll 35 participants.\",\n  \"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.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"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.\",\n}",203,"Not specified in the trial record.","Not stated in the trial record.",[21],"v2"]