Zenith(R) Connection Endovascular Covered Stent Clinical Study

Aorto-iliac Aneurysms Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00893620
• Other study ID #: 08-007
• Secondary ID: 370020, BVCT
• Status: Terminated
• Phase: N/A
• First received: April 27, 2009
• Last updated: February 13, 2017
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aorto-iliac Aneurysms
• Iliac Aneurysm
• Iliac Aneurysms

Intervention

Device:
• Zenith(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.

Locations

Country	Name	City	State
Germany	St. Bonifatius Hospital GmbH	Lingen
Germany	St. Franziskus Hospital	Muenster
Hong Kong	Queen Mary Hospital	Hong Kong
United Kingdom	Manchester Royal Infirmary	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Countries where clinical trial is conducted

Germany,  Hong Kong,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deployment and procedural outcome		30 days