Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study

Purpose

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.

Conditions

  • Congenital Heart Disease
  • Congenital Heart Disease (CHD)

Eligibility

Eligible Ages
Between 1 Minute and 6 Months
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Parental or legal authorized representative provide consent for study enrollment 2. Infants < 6 months of age 3. Diagnosis of congenital heart defect with ductal-dependent pulmonary circulation requiring infusion of prostaglandins 4. Requires ductus arteriosus stent diameters of 3.5mm or 4mm and stent lengths between 16mm and 28mm

Exclusion Criteria

  1. Active blood stream infection 2. Active or history of endocarditis 3. Body weight <2.5kg 4. Gestational age <32 weeks at birth 5. Complete heart block 6. Total Anomalous Pulmonary Venous Return 7. Anatomic variation judged to be inappropriate for ductal stenting per the treating interventionalist 8. Presence of an aortopulmonary collateral that is expected to require unifocalization 9. Non-confluent pulmonary arteries (i.e. isolated pulmonary artery of ductal origin) or bilateral patent ductus arteriosus (PDA) 10. Pulmonary atresia with intact ventricular septum with RV-dependent coronary circulation 11. Currently participating in an investigational drug study or another device study that would confound the study results 12. Patient who is on extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), or dialysis prior to ductal stenting procedure 13. Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.) 14. 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 15. 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 16. 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 17. Contraindications to peri-procedural anticoagulation 18. Known to be non-responsive to aspirin or other antiplatelet therapies 19. Known hypersensitivity or allergy to Nickel 20. Known hypersensitivity to contrast media that cannot be adequately pre-medicated

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Single Arm - Treatment 		Treatment with the Lifeline Ductus Arteriosus Stent
  • Device: Ductus Arteriosus Stent
    The eligible subjects will proceed to implantation of the Lifeline Ductus Arteriosus Stent to maintain patency of the PDA.
    Other names:
    • Stent
    • Pediatric Stent

Recruiting Locations

UCLA Mattel Children's
Los Angeles, California 90095
Contact:
Kirby Johnson
310-267-7600
kirbyjohnson@g.ucla.edu

Leland Stanford Junior University
Stanford, California 94305
Contact:
Kifle Yohannes
650-724-4661
kifley@stanford.edu

Children's Hospital Colorado
Aurora, Colorado 80045
Contact:
Madison McPherson
720-777-8403
madison.mcpherson@childrenscolorado.org

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
Contact:
Amy Pajk
513-803-0380
amy.pajk@cchmc.org

Nationwide Children's Hospital
Columbus, Ohio 43205
Contact:
Victoria Shay
614-355-5819
victoria.shay@nationwidechildrens.org

Texas Children's Hospital - Baylor College of Medicine
Houston, Texas 77030
Contact:
Mauricio Yanez
832-825-5953
mxyanez1@texaschildrens.org

Seattle Children's Hospital
Seattle, Washington 98105
Contact:
Jeremy Gillis
206-987-6580
Jeremy.gillis@seattlechildrens.org

More Details

Status
Recruiting
Sponsor
Starlight Cardiovascular Inc

Study Contact

Mary Beth Tate, BSBE-MBA
734-709-2080
marybeth.tate@globalmedicaldeviceconsultants.com

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.