PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study

Cook Group

Status: Completed

Conditions: Aortoiliac Aneurysms; Iliac Aneurysms

Treatments: Device: Zenith® Flex AAA Endovascular Graft; Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,; Device: Atrium iCAST™

Study type: Interventional

Funder types: Industry

Identifiers

NCT02571907

05-625 P2

Details and patient eligibility

About

The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac aneurysms.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• An aortioiliac or iliac aneurysm
• An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac 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
• Pregnant, breast-feeding or planning on becoming pregnant prior to completion of the study
• Unwilling or unable to comply with the follow-up schedule
• Simultaneously participating in another investigative device or drug study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Zenith® Branch Endovascular Graft-Iliac Bifurcation

Experimental group

Description:

Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft

Treatment:

Device: Atrium iCAST™

Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,

Device: Zenith® Flex AAA Endovascular Graft