Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections

Inclusion Criteria

- Subject signed an informed consent.

- Subject is at least 18 years old.

- Subject has an acute, complicated Type B aortic dissection with evidence of at least
one of the following:

- Malperfusion (visceral, renal, spinal cord and/or lower limb ischemia)

- Visceral ischemia measured by either radiographic or clinical evidence.

- Renal ischemia measured by either radiographic or clinical evidence.

- Spinal cord ischemia measured by either radiographic or clinical evidence.

- Lower limb ischemia measured by either radiographic or clinical evidence.

- Rupture - Measured by radiographic or clinical evidence.

- Subject is hemodynamically stable.

- Subject's anatomy must meet all of the following anatomical criteria:

Proximal landing zone aortic diameter must be between 20 mm and 44 mm;

- Centerline distance from distal margin of left CCA or in cases of bovine anatomy,
innominate artery, to start of most proximal tear must be ≥ 20 mm;

- Subject has patent iliac or femoral arteries or can tolerate an iliac conduit that
allows endovascular access to the dissection site with the delivery system of the
appropriate sized device.

- Thoracic aortic dissection is confirmed, at a minimum, by diagnostic contrast-enhanced
computerized tomography angiogram (CTA) with 3-D reconstruction, and/or contrast
enhanced magnetic resonance angiogram (MRA) obtained prior to the implant procedure.

Exclusion Criteria

- Planned placement of the COVERED portion of the stent graft over the left carotid
artery, or the celiac trunk.

- Subject has systemic infection.

- Subject is pregnant.

- Subject has received a previous stent or stent graft or previous surgical repair in
the DTA.

- Subject has had a cerebral vascular accident (CVA) within 2 months.

- Subject has a history of bleeding diathesis, coagulopathy, or refuses blood
transfusion.

- Subject has a history of Marfan Syndrome or other connective tissue disorder.

- Subject is currently participating in an investigational drug or device clinical trial
which would interfere with the endpoints and follow-ups of this study.

- Subject has a known allergy or intolerance to the device components.

- Subject has a known hypersensitivity or contraindication to anticoagulants or contrast
media, which is not amenable to pre-treatment.

- Subject has a co-morbidity causing expected survival to be less than 1 year.