Clinical trial NCT00833924: Zenith(R) Low Profile AAA Endovascular Graft Clinical Study
Official title: Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysms
Iliac Aneurysms
Aorto-iliac Aneurysms
Keywords: Low Profile
Abdominal Aortic Aneurysms
Endovascular
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2009-02-02
Enrollment: 120
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 Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.


Eligibility criteria: Inclusion Criteria:

* Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size
* Vessels suitable for endovascular access and aneurysm repair

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 With Major Adverse Events (MAE)
timeFrame: 30-day
measure: Patients With Device Failures
timeFrame: 12-month
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco, Div. Vascular Surgery and San Francisco VAMC
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: New Haven
country: United States
facility: Yale New Haven School of Med., Dept. of Vascular Surgery
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida, Vascular Surgery
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Butterworth
state: Michigan
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: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital
state: Missouri
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: New York
country: United States
facility: New York University Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Cornell
state: New York
city: Rochester
country: United States
facility: University of Rochester, Strong Memorial Hospital
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
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
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: Falls Church
country: United States
facility: Fairfax Inova Hospital
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Munster
country: Germany
facility: St. Franziskus Hospital
city: Moscow
country: Russian Federation
facility: CELT Hospital
city: Malmo
country: Sweden
facility: Malmo University Hospital
Study officials:
affiliation: University of Pennsylvania
name: Ronald Fairman, MD
role: PRINCIPAL_INVESTIGATOR
References: