Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts

Purpose

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.

Conditions

  • Juxtarenal Aortic Aneurysms
  • Suprarenal Aortic Aneurysms
  • Type IV Thoracoabdominal Aortic Aneurysms

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Endovascular 		The study will include patients treated by endovascular aortic repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft. The graft includes combinations of scallops, holes (fenestrations) or cuffs (side branches) . These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches. Other names: Endovascular stent Stent-graft
  • Device: Custom-made Zenith® Fenestrated AAA Endovascular Graft:
    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

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Safa Savadi Osgouei, MD
713-486-5361
Safa.savadiosgouei@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
Gustavo Oderich

Study Contact

Safa Savadi Osgouei, MD
(713) 486-5361
Safa.savadiosgouei@uth.tmc.edu

Detailed 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.