Fenestrated AAA Endovascular Graft Post-Approval Study

Cook Group

Status: Completed

Conditions: Abdominal Aortic Aneurysm (AAA); Juxtarenal Aneurysm; Aorto-iliac Aneurysm

Treatments: Device: Zenith® Fenestrated AAA Endovascular Graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT01990950

11-005

Details and patient eligibility

About

This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• abdominal aortic and aortoiliac aneursyms with a diameter greater than or equal to 5 cm
• aortic or aortoiliac aneurysm with a history of growth greater than or equal to 0.5 cm per year, or clinical indication for AAA repair

Exclusion criteria

• proximal neck less than 4mm 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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21 participants in 1 patient group

Zenith® Fenestrated AAA Endovascular Graft

Experimental group

Treatment:

Device: Zenith® Fenestrated AAA Endovascular Graft