Abdominal Aortic, Aorto-iliac Aneurysm
Conditions
Keywords
Aneurysm, Aortic Aneurysm, Aortic Aneurysm, Abdominal, Iliac Aneurysm, Vascular Diseases, Cardiovascular Diseases, Aortic Diseases
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.
Interventions
DEVICEZenith Alpha™ Abdominal Endovascular Graft
Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.
Sponsors
Cook Research Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed