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