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University of Utah PS-IDE: Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms

NCT07065760 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-15

No results posted yet for this study

Summary

The purpose of this study is to assess the effects of a physician-modified endovascular graft (PMEG) for juxtarenal aortic aneurysms by collecting data on its performance. Participants in the study will undergo surgery to repair their juxtarenal aortic aneurysm using the PMEG device. After the surgery, participants will attend several follow-up visits to monitor their recovery and the device's effectiveness. These follow-up visits will take place at hospital discharge, then at 1 month, 6 months, 12 months, and once a year for up to 5 years after surgery.

Conditions

  • Juxtarenal Abdominal Aortic Aneurysm

Interventions

DEVICE

Endovascular Aneurysm Repair with Physician Modified Endograft

The surgeon will make an incision to access the femoral artery and insert a thin wire to guide the catheter to the juxtarenal aortic aneurysm. The main graft will be modified by hand to match the participant's anatomy, then reloaded and guided through the artery to the aorta. Once in place, the graft will be deployed, and additional stents will be inserted into vital arteries that supply the kidneys and bowels. Two smaller grafts will be placed into the iliac arteries.This allows blood to flow to the target organs and legs, protecting the aneurysm from rupture. All catheters will then be removed, leaving the graft in place, and the incisions will be closed.

Sponsors & Collaborators

  • Cali Johnson

    lead OTHER

Principal Investigators

  • Cali Johnson, MD, EdD · University of Utah

  • Nathan Droz, MD · University of Utah

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2027-08-01
Completion
2032-08-01
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 NCT07065760 on ClinicalTrials.gov