Clinical Outcomes and Major Adverse Events in Patients Treated With Physician-Modified Fenestrated and Branched Stent Grafts

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06526676
Status
Recruiting
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Conditions

  • Juxtarenal Aortic Aneurysm
  • Pararenal Aneurysm
  • Thoracoabdominal Aortic Aneurysm

Eligibility Criteria

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

Interventions

  • Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent Graft — DEVICE
    Physician-modified stent grafts that utilizes multiple stent grafts with a combination of fenestrations and/or branches

Study Details

The purpose of this study is to evaluate safety and effectiveness of endovascular treatment of juxtarenal, pararenal and thoracoabdominal aortic aneurysms (with or without iliac artery involvement) using physician-modified stent grafts with a combination of fenestrations and/or branches.

Key Dates

Start date
Dec 2, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2032

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Subjects with short neck infrarenal, juxtarenal, suprarenal and extent IV TAA
    Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft
  • Experimental: Subjects with thoracoabdominal aortic aneurysms
    Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft
  • Experimental: Subjects with urgent or emergent aneurysms
    Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft

Primary Outcome Measure

Number of patients with major adverse events [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095
Kate M Horiuchi, MPH
[email protected]
(310) 267-1039
Bernardo C Mendes, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California, Los Angeles· Los Angeles, CA

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