PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study
- Conditions
- Aortoiliac AneurysmsIliac Aneurysms
- Registration Number
- NCT02571907
- Lead Sponsor
- Cook Research Incorporated
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- An aortioiliac or iliac aneurysm
- An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac artery
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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. 6 months
- Secondary Outcome Measures
Name Time Method Freedom From Morbidity (i.e., Morbidity Index) 30 days 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).
Trial Locations
- Locations (28)
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
Scroll for more (18 remaining)Mayo Foundation for Medical Education and Research🇺🇸Phoenix, Arizona, United States