Zenith TX2® Post-market Approval Study

This study is currently recruiting participants.

Verified by Cook, July 2009

First Received: December 19, 2008 Last Updated: July 14, 2009 History of Changes

Sponsored by:	Cook
Information provided by:	Cook
ClinicalTrials.gov Identifier:	NCT00813358

Purpose

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.

Condition	Intervention
Descending Thoracic Aortic Aneurysm	Device: Zenith TX2® TAA Endovascular Graft

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Zenith TX2® TAA Endovascular Graft Post-approval Study

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:

Thoracic aortic aneurysm-related mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	115
Study Start Date:	May 2009
Estimated Study Completion Date:	January 2017
Estimated Primary Completion Date:	January 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Endovascular repair: Experimental treatment	Device: Zenith TX2® TAA Endovascular Graft Endovascular treatment with the study device

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813358

Contacts

Contact: Michael Otlewski

765-463-7537

otlewski@medinst.com

Locations

United States, New York
University of Rochester Medical Center	Recruiting
Rochester, New York, United States, 14642
Contact: Michael Singh, MD 585-273-1745 michael_singh@urmc.rochester.edu

Sponsors and Collaborators

Cook

More Information

No publications provided

Responsible Party:	Cook Incorporated ( April Lavender / Vice President for Regulatory Affairs )
Study ID Numbers:	08-005, 370024, 2PAS
Study First Received:	December 19, 2008
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00813358 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Aortic Diseases
Aortic Aneurysm, Thoracic
Aneurysm
Vascular Diseases
Aortic Aneurysm

Additional relevant MeSH terms:

Aortic Diseases
Aortic Aneurysm, Thoracic
Aneurysm

Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm

ClinicalTrials.gov processed this record on August 28, 2009