Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study

Cook Group

Status: Completed

Conditions: Juxtarenal Aneurysms; Aorto-iliac Aneurysms; Abdominal Aortic Aneurysms

Treatments: Device: Zenith(R) Fenestrated AAA Endovascular Graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT00875563

04-541

370015, FNCT

Details and patient eligibility

About

The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm

Exclusion criteria

• Proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
• Renal artery stenosis greater than 50 percent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

1

Experimental group

Description:

Zenith(R) Fenestrated AAA Endovascular Graft

Treatment:

Device: Zenith(R) Fenestrated AAA Endovascular Graft