Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury
- Conditions
- Blunt Thoracic Aortic Injury
- Registration Number
- NCT01092767
- Lead Sponsor
- Medtronic Cardiovascular
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method All-cause Mortality Within 30-days of the Index Procedure 30 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
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
🇺🇸Saint Petersburg, Florida, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Scroll for more (15 remaining)University of Alabama🇺🇸Birmingham, Alabama, United States