PRESERVE-Zenith® Iliac Branch System Clinical Study

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.

Completed

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Key information

Conditions

Aorto-iliac Aneurysms Aneurysm Cardiovascular Diseases Iliac Aneurysm Iliac Aneurysms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto HCS, Palo Alto, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endovascular repair for aortoiliac or iliac aneurysms.

Device

Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ and the Zenith® Flex AAA Endovascular Graft.

Other names: Endovascular repair for aortoiliac or iliac aneurysm.

Primary outcomes

Patients That Are Free From Patency-related Intervention

Time frame: 6 Months

Patency-related intervention is defined as: Secondary intervention to treat a > 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2017
First posted: Sep 24, 2010
Registry last updated: Apr 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed