Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts

Last updated: January 16, 2026
Sponsor: Gustavo S Oderich
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Aneurysm

Cardiovascular Disease

Treatment

Custom-made Zenith® Fenestrated AAA Endovascular Graft:

Clinical Study ID

NCT01937949
H-57286
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft.

Eligibility Criteria

Inclusion

General Inclusion Criteria

  • A patient may be included in the study if the patient has at least one of the following and is appropriate for treatment with a custom-made Zenith® Fenestrated AAA Endovascular Graft:

  • Juxtarenal, suprarenal or type IV thoracoabdominal aortic aneurysm with a diameter ≥ 5.0 cm or 2 times the normal aortic diameter

  • Aneurysm with a history of growth ≥ 0.5 cm per year

  • Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.

General Exclusion Criteria

  • Less than 18 years of age

  • Unwilling to comply with the follow-up schedule

  • Inability or refusal to give informed consent by the patient or a legally authorized representative

  • Pregnant or breastfeeding

  • Life expectancy < 2-years

  • Additional medical restrictions as specified in the Clinical Investigation Plan

  • Additional anatomical restrictions as specified in the Clinical Investigation Plan

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Custom-made Zenith® Fenestrated AAA Endovascular Graft:
Phase:
Study Start date:
August 01, 2013
Estimated Completion Date:
May 31, 2030

Study Description

This is a traditional device feasibility study intended to generate preliminary safety and efficacy information that may be used to plan an appropriate future study, or to inform further product development.

Connect with a study center

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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