Zenith TX2® Post-market Approval Study (TX2 2PAS)

Cook Group

Status: Completed

Conditions: Descending Thoracic Aortic Aneurysm

Treatments: Device: Zenith TX2® TAA Endovascular Graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT00813358

08-005

370024, 2PAS

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

Endovascular repair

Experimental group

Description:

treatment

Treatment:

Device: Zenith TX2® TAA Endovascular Graft