Zenith Alpha™ Abdominal Endovascular Graft

Completed

• Conditions: Aorto-iliac Aneurysm; Abdominal Aortic

• Registration Number: NCT03061825
• Lead Sponsor: Cook Research Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-23
• Study Start: 2017-05-24
• Status Verified: 2021-01
• Primary Completion: 2021-01-06
• Study Completion: 2021-01-06
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device Success	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.

Trial Locations

Locations (5)

London Health Sciences Center; 🇨🇦 London, Ontario, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Nova Soctia Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada

Vancouver Hospital and Health Science Center; 🇨🇦 Vancouver, British Columbia, Canada