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ClinicalTrials.gov Identifier: NCT03061825
Recruitment Status :
First Posted : February 23, 2017
Last Update Posted : January 15, 2021
Cook Research Incorporated
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Potential study patients with abdominal aortic or aorto-iliac aneurysm will be "screened " at the hospital.
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
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