Home › Aortic Aneurysm › NCT01937949

Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts

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

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• Custom-made Zenith® Fenestrated AAA Endovascular Graft: (device)

Sponsor: Gustavo S Oderich · Participants: 200 · Started: 2013-08

Contact the study team

• Andrea C Martinez, MS · Phone: 713-798-6835
• Ying Huang, MD, PhD · Phone: 832-355-4033

Official record on ClinicalTrials.gov — NCT01937949

Locations in the U.S.

Conditions

• Aortic Aneurysm

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.