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

Inclusion criteria

• Presence of TAAA in:
• Men with TAAA greater than or equal to 6 cm in diameter
• Women with TAAA greater than or equal to 5 cm in diameter
• Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year
• Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or
• Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter
• Life expectancy more than 2 years
• Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol
• Suitable arterial anatomy for endovascular TAAA repair with "TAAA device":
• Proximal aortic landing zone:
• ≥ 20mm long
• ≤ 40mm and ≥ 20mm diameter in parallel aorta
• free from circumferential thrombus
• ≤ 60 degrees angulation
• Mesenteric/renal aortic diameter ≥ 20mm
• Mesenteric arteries:
• ≥ 10mm long segment of healthy artery for branch attachment
• Diameter ≥ 4mm and ≤ 12mm
• Absence of aberrant or early branching, aneurysm or dissection
• Renal arteries:
• ≥ 10mm long segment of healthy artery for branch attachment
• Diameter ≥ 4mm and ≤ 8mm
• Absence of aberrant or early branching, aneurysm or dissection
• Iliac artery access:
• ≥ 6mm diameter, and absence of severe calcification and tortuosity
• Or, planned creation of surgical conduit for TAAA device delivery
• 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
• Patients deemed high risk for open repair (meeting one, or more, of the following criteria):
• Age ≥ 65 year
• 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)
• Pulmonary disease:
• Home oxygen therapy
• FEV1 \< 1.2 l/s
• Vital capacity \< 50% predicted
• PaCO2 \> 45 mm Hg or \< 60 mm Hg
• Renal disease:
• ESRD on dialysis
• Prior aortic surgery
• Hostile abdomen
• Portal hypertension (ascites or varices)
• Coagulopathy AORTIC ARCH STUDY ARM Inclusion Criteria:
• Presence of aortic arch aneurysm in:
• Men with aortic arch aneurysm greater than or equal to 6 cm in diameter, or
• Women with aortic arch aneurysm greater than or equal to 5 cm in diameter, or
• Men with aortic arch aneurysm larger than 5 cm in diameter and enlarging at a rate of more than 10 mm/year, or
• Women with aortic arch aneurysm larger than 4.5 cm in diameter and enlarging at a rate of more than 10 mm/year, or
• Saccular aortic arch aneurysms deemed at significant risk for rupture based upon physician interpretation
• Life expectancy more than 2 years
• Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol.
• Suitable arterial anatomy for endovascular aortic arch repair with "Aortic Arch Device":
• Aneurysm of the aortic arch beginning distal to the native coronary arteries or any patent coronary artery bypass
• Proximal aortic landing zone:
• Native aorta or surgical graft
• ≥ 20 mm long
• ≤ 42 mm and ≥ 20 mm diameter in parallel aorta
• free from circumferential thrombus
• Distal aortic landing zone:
• Native aorta or surgical graft
• ≥ 20 mm long
• ≤ 42 mm and ≥ 20 mm diameter in parallel aorta
• free from circumferential thrombus
• ≥ 50mm length from native coronary arteries or patent coronary bypass graft to innominate artery
• Adequate supra-aortic trunk branch landing zone(s):
• Innominate artery (if applicable):
• Native vessel or surgical graft
• Diameter: 8-22mm
• Length of sealing zone ≥10mm
• Acceptable tortuosity
• Absence of dissection in landing zone
• Left (or right) common carotid artery (if applicable):
• Native vessel or surgical graft
• Diameter 6-16mm
• Length of sealing zone ≥10mm
• Acceptable tortuosity
• Absence of dissection in landing zone
• Left (or right) subclavian artery (if applicable):
• Native vessel or surgical graft
• Diameter: 5-20mm
• Length of sealing zone ≥10mm
• Acceptable tortuosity
• Absence of dissection in landing zone
• Iliac artery access:
• ≥ 6mm diameter, and absence of severe calcification and tortuosity
• Or, planned creation of surgical conduit for TAAA device delivery
• Patients deemed high risk for open surgical aortic arch repair based upon consensus of both a qualified cardiac surgeon and a qualified vascular surgeon and meeting one, or more, of the following criteria):
• Age \> 70 years-old
• Prior ascending or aortic arch repair
• Multiple (≥2) median sternotomies
• Ischemic cardiomyopathy with multi-level coronary artery disease and/or positive stress test
• Chronic pulmonary disease with FEV1 \< 1500ml
• Chronic kidney disease with eGFR ≤ 60 ml/kg/hr
• Large aneurysm abutting the sternotomy
• Severe deconditioning or immobility
• Prior cervical irradiation
• Other medical condition associated with prohibitive high risk with open repair based upon multidisciplinary consensus (cardiac surgery and vascular surgery) APPLIES TO BOTH STUDY ARMS

Exclusion criteria

• Rupture, with hypotension (systolic bp \< 90).
• Pregnancy or breastfeeding.
• Unwillingness or inability to comply with the follow up schedule.
• Serious systemic or groin infection.
• Uncorrectable coagulopathy.
• Age \< 18 years.
• Mycotic aneurysm.
• Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome (unless proximal implantation is into a previously placed surgical graft).
• Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold.
• Participation in another in another investigational device or drug study within 1 year of treatment.
• 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)
• Body habitus that would inhibit X-ray visualization of the aorta.
• Acute aortic dissection
• Patients able and willing to be treated with a commercially available device or a device being evaluated in a manufacturer-sponsored pivotal study