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
- Interventions
- Device: Valiant Thoracic Stent Graft with the Captivia Delivery System
- 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
- Arm && Interventions
Group Intervention Description Valiant Thoracic Stent Graft with the Captivia Delivery System Valiant Thoracic Stent Graft with the Captivia Delivery System Valiant Thoracic Stent Graft with the Captivia Delivery System
- 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
Denver Health
🇺🇸Denver, Colorado, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Bayfront Medical Center
🇺🇸Saint Petersburg, Florida, United States
University of Florida Shands Hospital
🇺🇸Gainesville, Florida, United States
Cooper Health
🇺🇸Camden, New Jersey, United States
Vascular Research Institute
🇺🇸Morristown, New Jersey, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Toledo Hospital / Jobst Vascular Center
🇺🇸Toledo, Ohio, United States
Brooke Army Medical Center
🇺🇸San Antonio, Texas, United States
Scott and White Memorial
🇺🇸Temple, Texas, United States
Sentara Norfolk General Vascular & Transplant Specialists
🇺🇸Norfolk, Virginia, United States
Laval Hospital
🇨🇦Quebec, Canada
Medical College of Wisconsin Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
London Health Sciences Center
🇨🇦London, Ontario, Canada
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Harbor UCLA
🇺🇸Torrance, California, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
Memorial Hermann Heart and Vascular Institute
🇺🇸Houston, Texas, United States
University of Miami Jackson Memorial
🇺🇸Miami, Florida, United States
University Of Virginia
🇺🇸Charlottesville, Virginia, United States