Laser In Situ Fenestration Study

Part of paid clinical trials in Columbia, Missouri.

Sponsor
Jonathan Bath
Study ID
NCT06411990
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Aneurysm
  • Endovascular Aneurysm Repair

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fenestrated Endovascular Aneurysm Repair using the LIFE Device System — DEVICE
    Fenestrated Endovascular Aneurysm Repair

Study Details

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.

Key Dates

Start date
Oct 15, 2024
Status verified
Mar 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2031

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Endovascular Aneurysm Repair
    Fenestrated Endovascular Aneurysm Repair using the LIFE Device System

Primary Outcome Measure

Number of participants with freedom from death and major adverse events (MAE) [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Missouri - ColumbiaColumbiaMissouri65212
Jonathan Bath, MD
[email protected]
573-882-8743
Jennifer Randolph, RN, BSN
[email protected]
(573) 882-4387

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By research site
University of Missouri - Columbia· Columbia, MO

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