Clinical trial NCT01208415: PRESERVE-Zenith® Iliac Branch System Clinical Study
Official title: PRESERVE-Zenith® Iliac Branch System Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aorto-iliac 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: 2010-09-24
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Patients That Are Free From Patency-related Intervention
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto HCS
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Boca Raton
country: United States
facility: Christine E. Lynn Heart and Vascular Institute
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
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: 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: 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: 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: