This trial is active, not recruiting.

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


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
Primary purpose treatment
Masking no masking
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 Zenith® Branch Endovascular Graft-Iliac Bifurcation.
atrium icast™
Implantation of Atrium iCAST
zenith® flex aaa endovascular graft
Implantation of the Zenith Flex Endovascular Graft

Primary Outcomes

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

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

Eligibility Criteria

All 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 March 2017.
Information provided to ClinicalTrials.gov by Cook.