Aorto-iliac Aneurysms, Iliac Aneurysms
Conditions
Keywords
iliac aneurysm, endovascular repair
Brief summary
The Zenith(R) Connection Endovascular Covered Stent Clinical Study is a clinical investigation to study the safety and performance of the Zenith(R) Connection Endovascular Covered Stent in conjunction with the Zenith(R) Branch Endovascular Graft-Iliac Bifurcation in the treatment of aorto-iliac and iliac aneurysms.
Interventions
DEVICEZenith(R) Connection Endovascular Covered Stent with the Zenith® Branch Endovascular Graft-Iliac Bifurcation and Zenith Flex(R) AAA Endovascular Graft
These devices will be used in patients with an unsuitable distal sealing site for the standard Zenith(R) iliac leg component proximal to the common iliac bifurcation to maintain internal iliac artery patency with endovascular aneurysm repair.
Sponsors
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* An aortoiliac or iliac aneurysm of appropriate size * Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery
Exclusion criteria
* Less than 18 years of age * Inability or refusal to give informed consent * Disease considerations that would compromise patient safety or study outcomes * Unsuitable arterial anatomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Deployment and procedural outcome | 30 days |
Countries
Germany, Hong Kong, United Kingdom
Outcome results
None listed