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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.
Implantation of Atrium iCAST
Implantation of the Zenith Flex Endovascular Graft
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
Freedom From Morbidity (i.e., Morbidity Index)
Morbidity index based on a composite endpoint of 31 pre-specified measure elements in seven categories (i.e., cardiovascular, pulmonary, renal, bowel, wound, neurologic, and vascular).
Time frame: 30 days
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Mayo Foundation for Medical Education and Research
Phoenix, Arizona, United States
VA Palo Alto HCS
Palo Alto, California, United States
Stanford University Medical School
Stanford, California, United States
Christine E. Lynn Heart and Vascular Institute
Boca Raton, Florida, United States
South Florida Medical Imaging
Fort Lauderdale, Florida, United States
University of Florida
Gainesville, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
St. Anthony's Medical Center
Rockford, Illinois, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, United States
University of Kentucky Hospital
Lexington, Kentucky, United States
...and 18 more locations