Zenith Alpha™ Abdominal Endovascular Graft

Aorto-iliac Aneurysm Clinical Trial

Official title:

Post-Market Study for Zenith Alpha™ Abdominal Endovascular Graft

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03061825
• Other study ID #: 15-10
• Status: Completed
• Start date: May 24, 2017
• Est. completion date: January 6, 2021

Study information

• Verified date: January 2021
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 6, 2021
• Est. primary completion date: January 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic
• Aneurysm
• Aorto-iliac Aneurysm
• Iliac Aneurysm

Intervention

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

Locations

Country	Name	City	State
Canada	Nova Soctia Health Authority	Halifax	Nova Scotia
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	London Health Sciences Center	London	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Vancouver Hospital and Health Science Center	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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