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

Feasibility, Safety, and Clinical Outcomes of Endovascular Treatment of Thoracoabdominal Aortic Aneurysms and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts

Prospective, nonrandomized, single-center, two-arm study to assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery.

To assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery in two study arms:

1. TAAA (thoracoabdominal aortic aneurysm) Study Arm: To assess the feasibility and safety and to evaluate clinical outcomes of endovascular stent graft implantation using either a multibranched stent graft (Off-the-Shelf TAAA Device) or custom-manufactured physician-specified branched and/or fenestrated stent graft (Physician-Specified TAAA Device) to treat aortic aneurysms involving the mesenteric and/or renal arteries (TAAA) in patients at high risk for open surgery.
2. Aortic Arch Study Arm: To assess the feasibility and safety and to evaluate clinical outcomes of endovascular stent graft implantation using 1) physician-specified aortic arch stent graft device with up to 3 antegrade and/or retrograde branches or 2) a physician-specified retrograde left subclavian branch stent-graft with double or triple wide scallop to the left common carotid artery] to treat aortic aneurysms involving the aortic arch in patients at high risk for open surgery.

TAAA STUDY ARM

Inclusion 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

AORTIC ARCH STUDY ARM

Inclusion Criteria:

1. Presence of aortic arch aneurysm in:

   1. Men with aortic arch aneurysm greater than or equal to 6 cm in diameter, or
   2. Women with aortic arch aneurysm greater than or equal to 5 cm in diameter, or
   3. Men with aortic arch aneurysm larger than 5 cm in diameter and enlarging at a rate of more than 10 mm/year, or
   4. Women with aortic arch aneurysm larger than 4.5 cm in diameter and enlarging at a rate of more than 10 mm/year, or
   5. Saccular aortic arch aneurysms deemed at significant risk for rupture based upon physician interpretation

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 aortic arch repair with "Aortic Arch Device":

   1. Aneurysm of the aortic arch beginning distal to the native coronary arteries or any patent coronary artery bypass

   2. 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

   3. 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

   4. 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

   5. Iliac artery access:

      • ≥ 6mm diameter, and absence of severe calcification and tortuosity
      • Or, planned creation of surgical conduit for TAAA device delivery

5. 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):

   1. Age > 70 years-old
   2. Prior ascending or aortic arch repair
   3. Multiple (≥2) median sternotomies
   4. Ischemic cardiomyopathy with multi-level coronary artery disease and/or positive stress test
   5. Chronic pulmonary disease with FEV1 < 1500ml
   6. Chronic kidney disease with eGFR ≤ 60 ml/kg/hr
   7. Large aneurysm abutting the sternotomy
   8. Severe deconditioning or immobility
   9. Prior cervical irradiation
   10. 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:

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