Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic

Eligibility Criteria

• 1. Patient is \> 18 years of age
• 2. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
• 3. Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
• 4. Patient is considered by the treating physician to be at high risk of open surgical repair due to one or more major medical co-morbidities (i.e. CAD, CHF, COPD, CRI, advanced age, generalized deconditioning, or other.) with ASA of 3 or more.
• 5. The patient has a life expectancy of greater than 1 year.
• 6. The patient has a thoraco-abdominal aortic aneurysm where necessary visceral branch vessels (i.e. the celiac, superior mesenteric, inferior mesenteric, renal and/or dominant spinal arteries) arise from the aneurysm or seal zones necessary for on-label thoracic endovascular repair
• 7. Patient has a thoraco-abdominal aortic aneurysm that meets at least one of the following:
• * aneurysm \> 5.5 cm in diameter
• * aneurysm has increased in size by 0.5 cm in last 6 months
• * aneurysm is believed to be causing symptoms
• 8. Patient has sufficient arterial access (femoral and/or iliac) that will allow delivery of the endovascular device with or without the use of a surgical conduit.
• 9. Patient has suitable proximal (aorta) and distal (aorta or iliac) arteries to allow for adequate fixation and seal:
• 1. with a length of 25 mm of proximal seal in non-aneurysmal aorta, with or without coverage of the left subclavian artery,
• 2. with an outer wall diameter of no less than 20 mm and no greater 38mm, and
• 3. With a length of at least 15 mm,
• 4. Aortic seal zone no less than 15 mm and no greater than 38 mm or Iliac seal zone with an outer wall diameter of no less than 8 mm and no greater than 23 mm.
• 10. The patient has no more than 5 necessary visceral arteries that require flow preservation.
• 11. All target visceral artery seal zones are \> 4 mm in diameter. 12. Patient must be willing to comply with all required follow-up exams.
• 1. Patient has an active systemic infection
• 2. Patient has a mycotic aneurysm.
• 3. Patient has a known hypersensitivity to contrast media that is not amenable to pre-treatment.
• 4. Patient has an absolute contra-indication to anticoagulation
• 5. Patient has a known allergy or intolerance to stainless steel, nickel, or gold
• 6. Patient has a body habitus that would inhibit adequate X-ray visualization of the aorta
• 7. Patient has a dominant artery to the spinal cord arising from an area of stent graft coverage that is not amenable to preservation using an endovascular branch
• 8. Patient is currently participating in another investigational device or drug clinical trial
• 9. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
• 10. Patient has a freely ruptured TAAA with hemodynamic instability
• 11. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
• 12. Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned within 30 days of the TAAA repair. Adjunctive procedures for treatment of the TAAA (i.e. carotid-subclavian bypass or iliac conduit) are acceptable.
• 13. Patient has a history of connective tissue disease (e.g. Marfan or Ehlers Danlos syndromes)