Overview

This trial is active, not recruiting.

Conditions aortoiliac aneurysms, iliac aneurysms
Treatment zenith® branch endovascular graft-iliac bifurcation,
Sponsor Cook
Start date April 2015
End date November 2015
Trial size 40 participants
Trial identifier NCT02571907, 05-625 P2

Summary

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.

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)
Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
zenith® branch endovascular graft-iliac bifurcation, Branch Graft
Implantation of the following devices into each subject: Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Atrium iCAST™, and the Zenith® Flex AAA Endovascular Graft.

Primary Outcomes

Measure
Number of patients with freedom from patency-related intervention defined as a secondary intervention to treat a > 60 % stenosis of the internal iliac artery associated with clinical symptoms.
time frame: 6 months

Secondary Outcomes

Measure
Freedom from morbidity (i.e., morbidity index)
time frame: 30 days

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 - 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

Additional Information

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