The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection. A thoracic dissection is a tear in the wall of the aorta, that causes blood to flow between the layers of the aorta and force the layers apart (dissect). This condition is a medical emergency and can quickly lead to death. 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 device would be effective in treating dissections. Information will be collected on the performance of the device for 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
All subjects will be implanted with this device
USC Keck School of Medicine
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Harbor UCLA
Torrance, California, United States
Washington Hospital D.C.
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Northwestern Memorial
Chicago, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
New York Presbyterian Weill Cornell
New York, New York, United States
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
...and 7 more locations
All Cause Mortality.
Time frame: Up to 30 days after the stent graft implant.
All-cause Mortality
Time frame: at 12 months
Subjects With Successful Delivery and Deployment of the Device.
Time frame: At implant.
Subjects With Coverage of Primary Tear
Time frame: At implant
Aortic Rupture
Time frame: Within 30 days
Aortic Rupture
Time frame: Within 12 months
Subjects With Secondary Endovascular Procedures
Time frame: Through12 months
Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment
Time frame: At 6 months
Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment
Time frame: At 12 months
Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft
Time frame: at 6 months
Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft
Time frame: at 12 months
Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft
Time frame: at 6 months
Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft
Time frame: at 12 months
Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.
Time frame: at 30 days
Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.
Time frame: at 12 months
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