Fenestrated AAA Endovascular Graft Post-Approval Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2020-10-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Abdominal Aortic Aneurysm (AAA) Aorto-iliac Aneurysm Juxtarenal Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zenith® Fenestrated AAA Endovascular Graft

Group Type EXPERIMENTAL

Zenith® Fenestrated AAA Endovascular Graft

Intervention Type DEVICE

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 aneursyms having morphology suitable for endovascular repair

Interventions

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Zenith® 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 aneursyms having morphology suitable for endovascular repair

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No