Zenith TX2® Post-market Approval Study

Cook Research Incorporated115 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

115

Conditions

Descending Thoracic Aortic Aneurysm

Interventions

Zenith TX2® TAA Endovascular GraftDEVICE

Endovascular treatment with the study device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (25)

Kaiser Permanente

San Francisco, California, United States

Outcomes

Primary Outcomes

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

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.

Time frame: 5 years

Data from ClinicalTrials.gov

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