Zenith Alpha™ Abdominal Endovascular Graft

January 14, 2021 updated by: Cook Research Incorporated

Post-Market Study for 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • Vancouver Hospital and Health Science Center
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H3A7
        • Nova Soctia Health Authority
    • Ontario
      • Hamilton, Ontario, Canada, L8L2X2
        • Hamilton General Hospital
      • London, Ontario, Canada, N6A 4G5
        • London Health Sciences Center
      • Toronto, Ontario, Canada, M5G 1X6
        • Toronto General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Potential study patients with abdominal aortic or aorto-iliac aneurysm will be "screened " at the hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Research Incorporated

Investigators

  • Principal Investigator: Thomas Forbes, MD, Toronto General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 24, 2017

Primary Completion (ACTUAL)

January 6, 2021

Study Completion (ACTUAL)

January 6, 2021

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

February 21, 2017

First Posted (ACTUAL)

February 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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