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Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study

NCT07114718 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Ductus Arteriosus Stent

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Starlight Cardiovascular Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Minute
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-16
Primary Completion
2027-10-31
Completion
2028-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07114718 on ClinicalTrials.gov