Zenith Alpha™ Abdominal Endovascular Graft

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.

Completed

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Key information

Conditions

Abdominal Aortic Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Aorto-iliac Aneurysm Cardiovascular Diseases Iliac Aneurysm Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vancouver Hospital and Health Science Center, Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zenith Alpha™ Abdominal Endovascular Graft

Device

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

Primary outcomes

Device Success

Time frame: 2 years

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.

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

Post-Market Study for Zenith Alpha™ Abdominal Endovascular Graft

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: Feb 23, 2017
Registry last updated: Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed