Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury

Inclusion criteria

• Subject had a blunt thoracic aortic injury which:
• was confirmed, at a minimum, by diagnostic contrast-enhanced computerized tomography angiogram (CTA) and/or contrast-enhanced magnetic resonance angiogram (MRA)
• occurred no more than 30 days prior to the stent implant procedure
• Subject was ≥ 18 years of age
• Subject or subject's legally authorized representative signed an IRB approved informed consent
• Subject was hemodynamically stable
• Subject's anatomy met all of the following anatomical criteria:
• Aortic diameter (adventitia to adventitia) of the proximal and distal landing zones between 18 mm and 44 mm
• Subject had patent iliac or femoral arteries or could tolerate an iliac conduit that allowed endovascular access to the injury site with the delivery system of the appropriate sized device
• The centerline distance from the distal margin of left common carotid artery (LCC) to the injury was ≥ 20 mm

Exclusion criteria

• Planned placement of the COVERED portion of the stent graft over the celiac axis or the LCC, or in cases of bovine anatomy, innominate artery
• Subject had systemic infection
• Subject was pregnant
• Subject had received a previous stent or stent graft or previous surgical repair in the DTA
• Subject had a history of bleeding diathesis, coagulopathy, or refuses blood transfusion
• Subject was participating in an investigational drug or device clinical trial which would interfere with the endpoints and/or follow-ups of this study
• Subject had a known allergy or intolerance to the device components
• Subject had a known hypersensitivity or contraindication to anticoagulants or contrast media, which was not amenable to pre-treatment
• Subject was in extremis, defined as subject that had non-survivable injury/condition
• Subject had a Cerebral Vascular Accident (CVA) within two (2) months prior to implant procedure