Overview

This trial is active, not recruiting.

Conditions aorto-iliac aneurysms, iliac aneurysms
Treatment endovascular repair for aortoiliac or iliac aneurysms.
Sponsor Cook
Start date January 2011
End date October 2012
Trial size 40 participants
Trial identifier NCT01208415, 05-625-P1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
endovascular repair for aortoiliac or iliac aneurysms. Endovascular repair for aortoiliac or iliac aneurysm.
Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ and the Zenith® Flex AAA Endovascular Graft.

Primary Outcomes

Measure
Freedom from patency-related intervention
time frame: Procedure through 6-months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title PRESERVE-Zenith® Iliac Branch System Clinical Study
Principal investigator W. Anthony Lee, MD, FACS
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Cook.