Overview

Expanded access is currently available for this treatment.

Conditions aorto-iliac aneurysms, iliac aneurysms
Treatment zenith® branch endovascular graft-iliac bifurcation system
Sponsor Cook
Start date May 2012
End date April 2013
Trial identifier NCT02571985, 05-625 CA-P1

Summary

The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation System. This system is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms

United States No locations recruiting
Other Countries No locations recruiting

Eligibility Criteria

Male or female participants at least 18 years old.

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 - Unsuitable arterial anatomy

Additional Information

Official title Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation With the ConnectSX™
Principal investigator W. Anthony Lee, MD FACS
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Cook.