PRESERVE-Zenith® Iliac Branch System Clinical Study

Cook Group

Status: Completed

Conditions: Aorto-iliac Aneurysms; Iliac Aneurysms

Treatments: Device: Endovascular repair for aortoiliac or iliac aneurysms.

Study type: Interventional

Funder types: Industry

Identifiers

NCT01208415

05-625-P1

Details and patient eligibility

About

The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms.

Enrollment: 40 patients

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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40 participants in 1 patient group

Device Implant

Experimental group

Treatment:

Device: Endovascular repair for aortoiliac or iliac aneurysms.