Zenith Alpha™ Abdominal Endovascular Graft

Cook Research Incorporated100 enrolled

Overview

The purpose of this study is to evaluate the clinical performance of the Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Abdominal Aortic Aorto-iliac Aneurysm

Interventions

Zenith Alpha™ Abdominal Endovascular GraftDEVICE

Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A patient is considered eligible for inclusion in the study if the patient has an infrarenal abdominal aortic or aorto-iliac aneurysm and is intended to be treated with the Zenith Alpha™ Abdominal Endovascular Graft Exclusion Criteria: * Life expectancy less than (\<) 2 years * Inability or refusal to give informed consent by the patient or legally authorized representative * Unwilling or unable to comply with the study follow-up

Locations (5)

Vancouver Hospital and Health Science Center

Vancouver, British Columbia, Canada

Nova Soctia Health Authority

Halifax, Nova Scotia, Canada

Hamilton General Hospital

Hamilton, Ontario, Canada

London Health Sciences Center

London, Ontario, Canada

Outcomes

Primary Outcomes

Device Success

Technical success (successful introduction and deployment of the device in the absence of surgical conversion or mortality) plus freedom from the following: abdominal aneurysm rupture, conversion, Type I or III endoleak, graft limb occlusion and abdominal aneurysm size increase \> 5 mm.

Time frame: 2 years

Data from ClinicalTrials.gov

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