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Laser In Situ Fenestration Study

NCT06411990 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-03-28

No results posted yet for this study

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.

Conditions

  • Aortic Aneurysm
  • Endovascular Aneurysm Repair

Interventions

DEVICE

Fenestrated Endovascular Aneurysm Repair using the LIFE Device System

Fenestrated Endovascular Aneurysm Repair

Sponsors & Collaborators

  • University of Missouri-Columbia

    collaborator OTHER

  • Jonathan Bath

    lead OTHER

Principal Investigators

  • Jonathan Bath, MD · University of Missouri School - Columbia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2027-06-30
Completion
2031-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06411990 on ClinicalTrials.gov