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NCT Number: NCT01937949

Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts

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.

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Key information

Conditions

Juxtarenal Aortic Aneurysms Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Suprarenal Aortic Aneurysms Type IV Thoracoabdominal Aortic Aneurysms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Custom-made Zenith® Fenestrated AAA Endovascular Graft:

Device

The graft will be inserted through arteries in the groin (called endovascular repair). Endovascular repair is a procedure that uses catheters that go inside your blood vessel to place a stent graft above and below the aneurysm. This procedure lines the aneurysm with a new lining (stent) so blood does not fill the artery any more.

Other names: Endovascular stent, Stent-graft

Primary outcomes

  1. Number of subjects who have die at 30 days post treatment

    Time frame: 30 days post treatment]

    Deaths 30 days after treatment

  2. Number of subjects who experience a Major Adverse Event at 30 days post treatment

    Time frame: 30 days post treatment

    A Major Adverse Event includes any of the following: bowel ischemia, myocardial infarction (heart attack), paraplegia, renal failure, respiratory failure, stroke, or blood loss greater than 1000 ml.

Secondary outcomes

  1. Subject Scores on Short Form-36 (SF-36) Quality of Life Questionnaire

    Time frame: baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years.

    Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).

  2. Number of Subjects Who Achieve Treatment Success

    Time frame: 12 months

    Treatment success is defined by a composite end-point, which includes all the following criteria described below:

    • Technical success, defined as successful delivery and deployment of the custom-made endovascular graft with preservation of those branch vessels intended to be preserved.
    • Freedom from type I or III endoleak.
    • Freedom from stent-graft migration.
    • Freedom from aneurysm enlargement >5mm
    • Freedom from aneurysm rupture or conversion to open repair.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea C Martinez, MS

CONTACT

[email protected]

713-798-6835

Ying Huang, MD, PhD

CONTACT

[email protected]

832-355-4033

Sponsors and collaborators

Lead sponsor

Gustavo S Oderich

Other

Collaborators

  • Cook Group Incorporated

Registry information

Official study title

Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts

Important dates

Study start
2013
Primary completion
2025
Study completion
2030
First posted
Sep 10, 2013
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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