Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts

Gustavo S Oderich

Status: Enrolling

Conditions: Juxtarenal Aortic Aneurysms; Suprarenal Aortic Aneurysms; Type IV Thoracoabdominal Aortic Aneurysms

Treatments: Device: Custom-made Zenith® Fenestrated AAA Endovascular Graft:

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01937949

H-57286

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Endovascular

Other group

Description:

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

Treatment:

Device: Custom-made Zenith® Fenestrated AAA Endovascular Graft: