PRESERVE-Zenith® Iliac Branch System Clinical Study
- Conditions
- Iliac AneurysmsAorto-iliac Aneurysms
- Registration Number
- NCT01208415
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- An aortoiliac or iliac aneurysm of appropriate size
- Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Patients That Are Free From Patency-related Intervention 6 Months Patency-related intervention is defined as: Secondary intervention to treat a \> 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (19)
VA Palo Alto HCS
🇺🇸Palo Alto, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Christine E. Lynn Heart and Vascular Institute
🇺🇸Boca Raton, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital East Communities
🇺🇸Saint Louis, Missouri, United States
Scroll for more (9 remaining)VA Palo Alto HCS🇺🇸Palo Alto, California, United States