Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
A legfontosabb adatok
- Hol
- Aurora, Baltimore, Boston, Cincinnati, Columbus, Houston, Los Angeles, Philadelphia, San Diego, Seattle és Stanford (Egyesült Államok)Mind a 11 helyszín megnézése
Helyszínek itt: Egyesült Államok
- Children's Hospital ColoradoAurora, Egyesült ÁllamokContact: Maria DornonRésztvevőt keres
- Johns Hopkins Children's CenterBaltimore, Egyesült ÁllamokContact: Kate KalligyToborzás még nem indult
- Boston Children's HospitalBoston, Egyesült ÁllamokContact: Lizzy CooneyRésztvevőt keres
- Cincinnati Children's Hospital Medical CenterCincinnati, Egyesült ÁllamokContact: Amy PajkRésztvevőt keres
- Nationwide Children's HospitalColumbus, Egyesült ÁllamokContact: Victoria ShayRésztvevőt keres
- Texas Children's Hospital/ Baylor College of MedicineHouston, Egyesült ÁllamokContact: Lesley CruzRésztvevőt keres
- UCLA Mattel Children'sLos Angeles, Egyesült ÁllamokContact: Nicholas SharawayRésztvevőt keres
- Children's Hospital of PhiladelphiaPhiladelphia, Egyesült ÁllamokContact: Olivia MartinoRésztvevőt keres
- Rady Children's Hospital - San DiegoSan Diego, Egyesült ÁllamokContact: Yu XiaoyangRésztvevőt keres
- Seattle Children's HospitalSeattle, Egyesült ÁllamokContact: Jeremy GillisRésztvevőt keres
- Leland Stanford Junior UniversityStanford, Egyesült ÁllamokContact: Kifle YohannesRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Starlight Cardiovascular Inc
- Azonosító
- NCT07114718
- A regiszteradat frissítve
- 2026. október 29.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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; 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; Known to be non-responsive to aspirin or other antiplatelet therapies; Active blood stream infection; Active or history of endocarditis; Complete heart block; Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.); Known hypersensitivity or allergy to Nickel; Known hypersensitivity to contrast media that cannot be adequately pre-medicated; Gestational age <32 weeks at birth; Body weight <2.5kg; Total Anomalous Pulmonary Venous Return; 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; Contraindications to peri-procedural anticoagulation.