PRESERVE-Zenith® Iliac Branch System Clinical Study

Not Applicable

Completed

• Conditions: Iliac Aneurysms; Aorto-iliac Aneurysms
• Interventions: Device: Endovascular repair for aortoiliac or 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

Study Timeline

• Study First Submitted: 2010-09-23
• Study First Submitted QC: 2010-09-23
• Study First Posted: 2010-09-24
• Study Start: 2011-01
• Primary Completion: 2012-10
• Results First Submitted: 2017-07-18
• Results First Submitted QC: 2017-07-18
• Results First Posted: 2017-08-16
• Status Verified: 2017-09
• Study Completion: 2017-10-10
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• An aortoiliac or iliac aneurysm of appropriate size
• Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac 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
• Unsuitable arterial anatomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device Implant	Endovascular repair for aortoiliac or iliac aneurysms.	-

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.

Trial Locations

Locations (19)

VA Palo Alto HCS; 🇺🇸 Palo Alto, California, United States

Christine E. Lynn Heart and Vascular Institute; 🇺🇸 Boca Raton, Florida, United States

University of Massachusetts; 🇺🇸 Worcester, Massachusetts, United States

Mercy Hospital East Communities; 🇺🇸 Saint Louis, Missouri, United States

Weill Cornell Medical Center; 🇺🇸 New York, New York, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Aurora St. Luke's Hospital; 🇺🇸 Milwaukee, Wisconsin, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States