The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a blunt thoracic aortic injury (BTAI). BTAI is when the aorta has been injured due to traumatic force to the chest area. It is commonly caused by motor vehicle accidents. In most cases it is life threatening and the standard treatment is surgery. Many times when a person has a BTAI they also have other injuries that can affect the results of the surgery. Since stent grafting has been an effective way to treat other aortic conditions such as aneurysms (bulge in aorta wall), it is believed that the Valiant stent graft would be effective in treating BTAI. A stent graft is a woven polyester tube (graft) supported by a metal frame of strong but flexible nitinol (type of metal) springs (stent) that is placed in the aorta to help seal the injury and keep it from bleeding.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
All subjects will be implanted with this device
University of Alabama
Birmingham, Alabama, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Harbor UCLA
Torrance, California, United States
Denver Health
Denver, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
University of Florida Shands Hospital
Gainesville, Florida, United States
University of Miami Jackson Memorial
Miami, Florida, United States
Bayfront Medical Center
St. Petersburg, Florida, United States
Maine Medical Center
Portland, Maine, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
...and 15 more locations
All-cause Mortality Within 30-days of the Index Procedure
Time frame: 30 days
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