Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411990
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-30
Brief Title:
Laser In Situ Fenestration Study
Sponsor:
Jonathan Bath
Organization:
University of Missouri-Columbia
Study Overview
Official Title:
Laser In Situ Fenestration for Endovascular Aortic Repair LIFE Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
LIFE
Brief Summary:
The goal of this clinical trial is to learn about a new device named the LIFE device to treat people with aneurysms swellings in the aorta large main blood vessel that delivers blood from the heart to the body The main questions this trial aims to answer are
If the LIFE device works to treat aortic aneurysms
What medical problems participants have when the LIFE device is used Participants will undergo treatment with the LIFE device and thereafter at 30 days 6 months 1 year 2 years 3 years 4 years and 5 years have their pulses checked bloodwork to check kidney function BUN and serum creatinine and a CT scan of the aneurysm area
If the LIFE device works to treat aortic aneurysms
What medical problems participants have when the LIFE device is used Participants will undergo treatment with the LIFE device and thereafter at 30 days 6 months 1 year 2 years 3 years 4 years and 5 years have their pulses checked bloodwork to check kidney function BUN and serum creatinine and a CT scan of the aneurysm area
Detailed Description:
In this clinical trial the LIFE device is used to treat people with aneurysms in the aorta near the kidney arteries called juxtarenal or pararenal aortic aneurysms Tubes called stent grafts are typically inserted through blood vessels in the groin and placed inside the aorta in the abdomen and chest area endovascularly placed to cover the tear or leak in the aorta The LIFE device covers the tear or leak and has side branches to let blood flow into the kidney spleen intestine or liver arteries Participants in this study are not candidates for endovascular devices approved for endovascular aorta repair to the juxtarenal or pararenal aorta not candidates for open repair not willing to travel to sites that have access to manufacturer-made endovascular devices and patients for whom there are no favorable alternatives for example urgent symptomatic and emergency cases
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-001 | OTHER | University of Missouri | None |