Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts

Eligibility Criteria

• 1. Presence of TAAA in:
• 1. Men with TAAA greater than or equal to 6 cm in diameter
• 2. Women with TAAA greater than or equal to 5 cm in diameter
• 3. Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year
• 4. Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or
• 5. Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter
• 2. Life expectancy more than 2 years
• 3. Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol
• 4. Suitable arterial anatomy for endovascular TAAA repair with "TAAA device":
• 1. Proximal aortic landing zone:
• * ≥ 20mm long
• * ≤ 40mm and ≥ 20mm diameter in parallel aorta
• * free from circumferential thrombus
• * ≤ 60 degrees angulation
• 2. Mesenteric/renal aortic diameter ≥ 20mm
• 3. Mesenteric arteries:
• * ≥ 10mm long segment of healthy artery for branch attachment
• * Diameter ≥ 4mm and ≤ 12mm
• * Absence of aberrant or early branching, aneurysm or dissection
• 4. Renal arteries:
• * ≥ 10mm long segment of healthy artery for branch attachment
• * Diameter ≥ 4mm and ≤ 8mm
• * Absence of aberrant or early branching, aneurysm or dissection
• 5. Iliac artery access:
• * ≥ 6mm diameter, and absence of severe calcification and tortuosity
• * Or, planned creation of surgical conduit for TAAA device delivery
• 6. For patients with associated common iliac artery aneurysms (\>20mm diameter), adequate internal and external iliac artery landing zones and common iliac artery luminal diameter (for iliac branch device use):
• * ≥ 10mm long segment of healthy internal iliac artery for branch attachment
• * Internal iliac diameter ≥ 5mm and ≤ 12mm
• * External iliac diameter ≥ 6mm diameter, and absence of severe calcification and tortuosity
• * Minimum common iliac artery luminal diameter ≥ 14mm
• * Or, in patients with bilateral common iliac artery aneurysms without suitable anatomy, planned surgical bypass to maintain patency of at least one internal iliac artery
• 5. Patients deemed high risk for open repair (meeting one, or more, of the following criteria):
• 1. Age ≥ 65 year
• 2. Cardiac disease:
• * CAD (history of MI or angina with positive stress test and not revascularizable)
• * LV Ejection fraction \< 40%
• * Symptomatic CHF (NYHC Class II, III, or IV)
• 3. Pulmonary disease:
• * Home oxygen therapy
• * FEV1 \< 1.2 l/s
• * Vital capacity \< 50% predicted
• * PaCO2 \> 45 mm Hg or \< 60 mm Hg
• 4. Renal disease:
• * ESRD on dialysis
• * eGFR \< 60
• 5. Prior aortic surgery
• 6. Hostile abdomen
• 7. Portal hypertension (ascites or varices)
• 8. Coagulopathy
• 1. Rupture, with hypotension (systolic bp \< 90).
• 2. Pregnancy or breastfeeding.
• 3. Unwillingness or inability to comply with the follow up schedule.
• 4. Serious systemic or groin infection.
• 5. Uncorrectable coagulopathy.
• 6. Age \< 18 years.
• 7. Mycotic aneurysm.
• 8. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome (unless proximal implantation is into a previously placed surgical graft).
• 9. Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold.
• 10. Participation in another in another investigational device or drug study within 1 year of treatment.
• 11. Unrelated concomitant major surgical or interventional procedure(s) within 30 days of treatment date (with the exception of staged procedures planned as part of treatment)
• 12. Body habitus that would inhibit X-ray visualization of the aorta.
• 13. Acute aortic dissection
• 14. Patients able and willing to be treated with a commercially available device or a device being evaluated in a manufacturer-sponsored pivotal study