Zenith TX2® TAA Endovascular Graft Post-approval Study

Cook Research Incorporated25 sites in 2 countries115 target enrollmentJuly 10, 2009

ConditionsDescending Thoracic Aortic Aneurysm

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Descending Thoracic Aortic Aneurysm
Sponsor: Cook Research Incorporated
Enrollment: 115
Locations: 25
Primary Endpoint: Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 10, 2009

End Date

March 23, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cook Research Incorporated

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality

Time Frame: 5 years

Thoracic aortic aneurysm-related mortality defined as death from any cause occurring within 30 days of the initial procedure or a secondary intervention; or any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the treated aneurysm.