Clinical trial NCT00813358: Zenith TX2® Post-market Approval Study
Official title: Zenith TX2® TAA Endovascular Graft Post-approval Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Descending Thoracic Aortic Aneurysm
Keywords: Endovascular Aneurysm Repair
Aortic Aneurysm
Thoracic
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2008-12-23
Enrollment: 115
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 TX2® Post-market Approval Study is a clinical trial approved by US FDA to further study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment of thoracic aortic aneurysms.


Eligibility criteria: Inclusion Criteria:

* Descending thoracic aortic aneurysm with diameter greater than or equal to 5.0 cm; or
* Descending thoracic aortic aneurysm with a history of growth greater than or equal to 0.5 cm within the previous 12 months; or
* Descending thoracic aortic degenerative or atherosclerotic ulcers greater than or equal to 10 mm in depth and 20 mm in diameter

Exclusion Criteria:

* Age less than 18 years
* Other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years)
* Pregnant, breast-feeding, or planning on becoming pregnant within 24 months
* Unwilling or unable to comply with the follow-up schedule
* Inability or refusal to give informed consent
* Simultaneously participating in another investigative device or drug study

Primary outcomes:
measure: Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: Aurora
country: United States
facility: University of Denver Colorado
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Peoria
country: United States
facility: Heart Care Midwest
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Flushing
country: United States
facility: New York Hospital of Queens
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: Rochester
country: United States
facility: Strong Memorial Hospital
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: Dallas
country: United States
facility: DFW Vascular Group
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center at Dallas
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References: