Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study

NCT ID: NCT07114718

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2028-04-30

Brief Summary

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.

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.

Conditions

Congenital Heart Disease; Congenital Heart Disease (CHD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm - Treatment

Treatment with the Lifeline Ductus Arteriosus Stent

Group Type: OTHER

Ductus Arteriosus Stent

Intervention Type: DEVICE

The eligible subjects will proceed to implantation of the Lifeline Ductus Arteriosus Stent to maintain patency of the PDA.

Interventions

Ductus Arteriosus Stent

The eligible subjects will proceed to implantation of the Lifeline Ductus Arteriosus Stent to maintain patency of the PDA.

Intervention Type: DEVICE

Other Intervention Names

Stent; Pediatric Stent

Eligibility Criteria

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

• Minimum Eligible Age: 0 Minutes
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Starlight Cardiovascular Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Mary Beth Tate, BSBE-MBA

Role: CONTACT

marybeth.tate@globalmedicaldeviceconsultants.com

734-709-2080

Other Identifiers

2R44HL158304-04A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

G250132

Identifier Type: -

Identifier Source: org_study_id