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Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Continued Access Study

Zenith® Fenestrated AAA Endovascular Graft Clinical Study

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT02577562
Enrollment
Unknown
Registered
2015-10-16
Start date
Unknown
Completion date
Unknown
Last updated
2017-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysms, Aorto-iliac Aneurysms, Juxtarenal Aneurysms

Brief summary

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

Interventions

DEVICEZenith® Fenestrated AAA Endovascular Graft

The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair

Sponsors

Cook Group Incorporated
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026