MedTrace Logo

Physician Modified Endovascular Grafts for the Treatment of Juxtarenal Aortic Aneurysms

NCT06657794 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-06-24

No results posted yet for this study

Summary

The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be unsuitable candidates for open surgical repair, have limited or no other options for treatment, and having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device:

* acutely (i.e., treatment success and technical success);
* at 30 days (i.e., the rate of major adverse events (MAE)); and
* at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).

Conditions

  • Juxtarenal Aortic Aneurysm
  • Aortic Rupture

Interventions

DEVICE

Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system

A Physician Modified Endograft is a commercially available, off-the-shelf endograft that has been altered at the time of the procedure by creating fenestrations in the seal zone of the graft to preserve blood flow into vital branch vessels. These fenestrations are marked with medical grade gold markers to facilitate fluoroscopic visualization during the procedure. In order to prevent branch vessel occlusion, these branch vessels are typically stented with covered balloon expandable stents using standardized techniques.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Sean P Lyden, MD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-17
Primary Completion
2030-12-31
Completion
2030-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06657794 on ClinicalTrials.gov