NCT03061825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 24, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

3.6 years

First QC Date

February 20, 2017

Last Update Submit

January 14, 2021

Conditions

Abdominal AorticAorto-iliac Aneurysm

Keywords

AneurysmAortic AneurysmAortic Aneurysm, AbdominalIliac AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Interventions

Zenith Alpha™ Abdominal Endovascular GraftDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Vancouver Hospital and Health Science Center

Vancouver, British Columbia, V6T 2B5, Canada

Location

Nova Soctia Health Authority

Halifax, Nova Scotia, B3H3A7, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

London Health Sciences Center

London, Ontario, N6A 4G5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 1X6, Canada

Location

MeSH Terms

Conditions

AneurysmAortic AneurysmAortic Aneurysm, AbdominalIliac AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Thomas Forbes, MD

    Toronto General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2017

First Posted

February 23, 2017

Study Start

May 24, 2017

Primary Completion

January 6, 2021

Study Completion

January 6, 2021

Last Updated

January 15, 2021

Record last verified: 2021-01

Locations

CA(5)