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Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft
The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA \[Thoracic Aortic Aneurysm\] Endovascular Graft) is a clinical trial approved by the United States Food and Drug Administration (FDA) to study the safety and effectiveness of the Zenith TX2 TAA Endovascular Graft in the treatment of thoracic aortic aneurysms / ulcers.
The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA Endovascular Graft) is a clinical trial approved by the FDA to study the safety and effectiveness of the Zenith TX2(R) TAA Endovascular Graft in the treatment of thoracic aortic aneurysms / ulcers. Instead of making a large incision in the chest, the physician makes a small incision near the groin to insert and guide the graft into place in the aorta, relieving pressure on the aneurysm and helping to reduce the risk of rupture. The Zenith TX2 TAA Endovascular Graft is a reinforced fabric tube that is sized to the length of the aorta that needs to be covered to seal off the aneurysm / ulcer. The graft is made of a polyester material like that used in open surgical repair. Standard surgical suture is used to sew the graft material to a frame of self-expanding stainless steel stents, which provide support. The materials used in the Zenith TX2 system have a long history of use in medical implants.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Banner Desert Medical Center
Mesa, Arizona, United States
Arizona Heart Institute
Phoenix, Arizona, United States
University of California, San Francisco
San Francisco, California, United States
Stanford University Hospital and Clinics
Stanford, California, United States
Swedish Medical Center
Englewood, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Start Date
March 1, 2004
Primary Completion Date
July 1, 2007
Completion Date
May 1, 2013
Last Updated
August 18, 2014
260
ACTUAL participants
Endovascular repair
DEVICE
Surgical
PROCEDURE
Lead Sponsor
Cook Group Incorporated
Collaborators
NCT04246463
NCT04197648
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05395598