Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT07114718
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Sponsor:
Starlight Cardiovascular Inc
Organization:
Study Overview
Official Title:
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2R44HL158304-04A1 | NIH | None | https://reporter.nih.gov/quic… | View |