Prospective, nonrandomized, single-center, single-arm feasibility and safety study to assess
the feasibility and safety of endovascular stent-graft implantation using a standard
configuration branched and fenestrated stent graft (TAAA device) or physician-specified
branched and fenestrated stent grafts (Physician-Specified TAAA Devices) for treatment of
thoracoabdominal aortic aneurysms (TAAA) involving the mesenteric and renal arteries in
patients at high risk for open surgery.
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
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 4cm
2. Life expectancy more than 2 years.
3. Ability to give informed consent and willing to comply with the follow-up schedule.
4. Suitable arterial anatomy for endovascular TAAA repair with "TAAA device":
a) Proximal aortic landing zone: i) ≥ 20mm long ii) ≤ 40mm and ≥ 20mm diameter in
parallel aorta iii) free from circumferential thrombus iv) ≤ 60 degrees angulation
b) Mesenteric/renal aortic diameter ≥ 20mm
c) Mesenteric arteries: i) ≥ 10mm long segment of healthy artery for branch
attachment ii) Diameter ≥ 4mm and ≤ 12mm iii) Absence of aberrant or early branching,
aneurysm or dissection
d) Renal arteries: i) ≥ 10mm long segment of healthy artery for branch attachment ii)
Diameter ≥ 4mm and ≤ 8mm iii) Absence of aberrant or early branching, aneurysm or
e) Iliac artery access: i) ≥ 6mm diameter, and absence of severe calcification and
tortuosity ii) Or, planned creation of surgical conduit for TAAA device delivery f.
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): i. ≥ 10mm long segment of healthy internal
iliac artery for branch attachment ii. Internal iliac diameter ≥ 5mm and ≤ 12mm iii.
External iliac diameter ≥ 6mm diameter, and absence of severe calcification and
tortuosity iv. Minimum common iliac artery luminal diameter ≥ 14mm v. 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
a) Age ≥ 65 year b) Cardiac disease i) CAD (history of MI or angina with positive
stress test and not revascularizable) ii) LV Ejection fraction < 40% iii) Symptomatic
CHF (NYHC Class II, III, or IV) c) Pulmonary disease i) Home oxygen therapy ii) FEV1
< 1.2 l/s iii) Vital capacity < 50% predicted iv) PaCO2 > 45 mm Hg or < 60 mm Hg d)
Renal disease i) ESRD on dialysis ii) eGFR < 60 e) Prior aortic surgery f) Hostile
abdomen g) Portal hypertension (ascites or varices) h) Coagulopathy
1. Free rupture of the aneurysm.
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 or ruptured aneurysm.
8. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome.
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)
i) Body habitus that would inhibit X-ray visualization of the aorta.