Evaluation of Visceral Function Following Endovascular Aortic Aneurysm Repair Using Branched Stent- Grafts

Inclusion Criteria

• •Patients may be included in the study if the patient has at least one of the following and has aortic anatomy appropriate for treatment with the Zenith® p-Branch™, Zenith® t-Branch, or Physician Specified TAAA Endovascular Graft (Custom Manufactured Devices).
• •1. Aortic Aneurysm Diameter
• •a. TAAA (Type I - IV) (including pararenal subtypes) with orthogonal aortic diameter greater than or equal to 5 cm or b. greater than two times the normal aortic diameter
• •2. Rapid aortic enlargement (\> than or equal to 5mm in 1 year)
• •3. Presence of a saccular aneurysm at risk for rupture based on investigators evaluation
• •4. Iliac artery aneurysm ˃2.2 cm may be treated with the Zenith® Branch Endovascular Graft-Iliac Bifurcation when the iliac artery aneurysm is associated with the qualifying thoracoabdominal aneurysm treated in this study
• •1. Treatment not possible with a currently available non-modified approved device
• •2. Patient accepts to and is able to comply with lifetime follow-up
• •3. Patient accepts to and is able to provide informed consent prior to enrollment
• •4. No stroke with significant residual deficit or myocardial infarction within the last 12 months
• •5. No significant carotid bifurcation disease (\> 70% stenosis by NASCET criteria)
• •6. Absence of systemic or local infection that may increase the risk of endovascular graft infection
• •7. Patient determined to be a high-risk profile for open surgical repair considering any of the following items:
• •1. Anatomy: previous sternotomy or left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta), previous aortic surgery, large aneurysm abutting the sternum with risk of disruption during sternotomy, prior cervical or chest irradiation.
• •2. Physiology: ASA Category ≥ III, age \>70 years, previous myocardial infarction, coronary artery disease, or coronary artery stent, coronary stress test with a reversible perfusion defect, COPD, congestive heart failure
• •1. Aortic Aneurysm Diameter: Ascending and/or Arch aneurysm with or without aortic or aortoiliac aneurysm with orthogonal aortic diameter greater than two times the normal aortic diameter
• •2. Rapid aortic enlargement (≥ 5 mm in 1 year)
• •3. Presence of a saccular aneurysm at risk for rupture based on the investigators evaluation
• •4. Clinical indication for aneurysm repair based on symptoms
• •5. Concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria.
• •1\) There is enough space for the device to be deployed distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion 2) Ascending aortic length \>50 mm (greater curve distance from sinotubular junction to proximal aspect of the innominate artery) 3) Sealing zone in the ascending aorta \>40 mm in length and \<38 mm in diameter for native aorta (\<42 mm if surgical graft replacement in place) 4) Sealing zone in the great vessels of \>20 mm in length
• •Diameter of innominate artery used for sealing \< 20 mm
• •Diameter of CCA or subclavian artery used for sealing \< 16mm 5. Distal aortic fixation zone: Native aorta or surgical graft (endovascular device or Dacron graft) , diameter: 20-42mm, distal neck length ≥20mm 6) Access for device delivery to accommodate 22F or 24F sheath depending on device design.
• •7\) Sealing zone in the great vessels of ≥ 20 mm in length
• •Diameter of innominate artery used for sealing between 8 and 20 mm
• •Diameter of CCA or subclavian artery used for sealing between 6 and 16 mm.
• •Aortic dissection:
• •1. A true lumen size large enough for device deployment and to gain access into the target branches
• •2. A sealing zone in the target aorta (or surgical graft) that is proximal to the primary dissection, so that the graft would seal off the dissection lumen
• •3. A sealing zone in the target supra-aortic trunk vessels that is distal to the dissection or surgically created
• •4. Access into the true lumen from the groin and to at least one supra-aortic trunk vessel
• •If more distal disease is observed in the aorta
• •1. The repair might be coupled with a thoracoabdominal branched device
• •2. Iliac anatomy large enough to allow the delivery of the arch branch device which is loaded within a 20F-24F sheath. Iliac conduits may be set in place if necessary.