Zenith(R) Connection Endovascular Covered Stent Clinical Study
Not Applicable
Terminated
- Conditions
- Aorto-iliac AneurysmsIliac Aneurysms
- Interventions
- Device: Zenith(R) Connection Endovascular Covered Stent with the Zenith® Branch Endovascular Graft-Iliac Bifurcation and Zenith Flex(R) AAA Endovascular Graft
- Registration Number
- NCT00893620
- Lead Sponsor
- Cook Group Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Zenith(R) Connection Endovascular Covered Stent with the Zenith® Branch Endovascular Graft-Iliac Bifurcation and Zenith Flex(R) AAA Endovascular Graft Treatment
- Primary Outcome Measures
Name Time Method Deployment and procedural outcome 30 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
St. Franziskus Hospital
🇩🇪Muenster, Germany
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
St. Bonifatius Hospital GmbH
🇩🇪Lingen, Germany
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong