Zenith(R) Connection Endovascular Covered Stent Clinical Study

Cook Group

Status: Terminated

Conditions: Aorto-iliac Aneurysms; Iliac Aneurysms

Treatments: Device: Zenith(R) Connection Endovascular Covered Stent with the Zenith® Branch Endovascular Graft-Iliac Bifurcation and Zenith Flex(R) AAA Endovascular Graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT00893620

370020, BVCT

08-007

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

1

Other group

Description:

Treatment

Treatment:

Device: Zenith(R) Connection Endovascular Covered Stent with the Zenith® Branch Endovascular Graft-Iliac Bifurcation and Zenith Flex(R) AAA Endovascular Graft