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
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.
You may not be if
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.
Clareo Health | 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
