Clinical trial NCT02571907: PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study
Official title: Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortoiliac Aneurysms
Iliac Aneurysms
Keywords: Zenith aortoiliac aneurysm
Iliac aneurysm
Branch
Connections
Endovascular graft
Graft-iliac bifurcation
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2015-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: Freedom from morbidity (i.e., morbidity index)
timeFrame: 30 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Foundation for Medical Education and Research
state: Arizona
city: Palo Alto
country: United States
facility: VA Palo Alto HCS
state: California
city: Stanford
country: United States
facility: Stanford University Medical School
state: California
city: Boca Raton
country: United States
facility: Christine E. Lynn Heart and Vascular Institute
state: Florida
city: Fort Lauderdale
country: United States
facility: South Florida Medical Imaging
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Rockford
country: United States
facility: St. Anthony's Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Methodist Hospital of Indiana
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Hospital
state: Kentucky
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital East Communities
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Milwaukee
country: United States
facility: Aurora St. Luke's Hospital
state: Wisconsin
Study officials:
affiliation: Christine E. Lynn Heart and Vascular Institute
name: W. Anthony Lee, MD FACS
role: PRINCIPAL_INVESTIGATOR
References: