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Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)

IRB Number

08-144

ClinicalTrials.gov Identifier

NCT00805948

Trial Status

Open for Enrollment
Phase Post Market

Why is this study being done?

Medtronic (the manufacturer of the Captiva Thoracic Stent Graft System) is collecting information about the Captiva Thoracic Stent Graft System in this post approval study. The purpose of the study is to evaluate the long-term performance of the Captiva Thoracic Stent Graft System to gain additional information regarding the safety and effectiveness of it. This graft has been approved by the US Food and Drug Administration (FDA) for the treatment of descending thoracic aortic aneurysms.

Who is eligible to participate?

Male and non-pregnant female patients who are 18 years or older and have been diagnosed with a descending thoracic aortic aneurysm are eligible.

What is involved?

Patients will undergo a physical examination and a CT or MRA of their aneurysms. After hospital discharge, they will return to the clinic for 1 month, 6 month, and annual visits for five years at which they will undergo a physical examination, CT or MRA of the chest, and X-ray of the chest.

How long is the study?

Patients will be in the study for approximately five years.

Who can I contact for additional information?

Please contact Tiffany Whitaker, R.N., at (217) 545-2531 or email:twhitaker@siumed.edu

Who is the Principal Investigator of this study?

Kim Hodgson, MD

Where is the trial located?

Springfield, Illinois