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Clinical Trials/NCT01990950
NCT01990950CompletedNot Applicable

Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Post-Approval Study

Cook Research Incorporated6 sites in 1 country21 target enrollmentStarted: March 1, 2014Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
6
Primary Endpoint
Treatment Success : AAA Related Mortality
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Zenith® Fenestrated AAA Endovascular Graft

Experimental

Intervention: Zenith® Fenestrated AAA Endovascular Graft (Device)

Outcomes

Primary Outcomes

Treatment Success : AAA Related Mortality

Time Frame: 5 years

patients treated with the Zenith® Fenestrated AAA Endovascular Graft will have a rate of aneurysm-related mortality at 5 years that meets a performance goal of 18% ,

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (6)

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