Physician-modified Endovascular Graft for Repair of Complex Thoracoabdominal and Abdominal Aortic Aneurysms

This study is a prospective, single-center, non-randomized, single-arm study. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, computed tomography angiography (CTA) of chest, abdomen and pelvis, abdominal duplex ultrasound, creatinine measurement, quality of life questionnaire at specific, protocol-defined intervals for a period of five years following the physician-modified Cook Zenith® Alpha Endovascular Graft implant.

Inclusion criteria

• Age ≥ 18 years old
• Life expectancy > 2 year(s)
• Patient is considered to be at high risk of morbidity and mortality with open surgical repair
• A patient may be entered into the study if the patient has at least one of the following:

• Juxtarenal, suprarenal or a thoracoabdominal aortic aneurysm with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter
• Aneurysm with a history of growth ≥ 0.5 cm per year
• Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation
• Symptomatic juxtarenal, suprarenal or a thoracoabdominal aortic aneurysm
• Thoracoabdominal aortic aneurysms secondary to aortic dissection meeting above criteria
• Patient is considered to be at high risk of morbidity and mortality with open surgical repair
• Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
• Nonaneurysmal aortic segment proximal to the aneurysm (neck) with a:

• Minimum neck length of 20mm
• Diameter in the range of 21-38mm
• Angle less than 60° relative to the axis of the aneurysm
• Angle less than 60° relative to the axis of the suprarenal aorta
• Minimum branch vessel diameter greater than 5 mm
• Iliac artery distal fixation site greater than 10mm in length and diameter in the range of 8-21mm.

Exclusion criteria

• Under the age of 18 years
• Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
• Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
• Willing to participate in a sponsor-investigator IDE with access to a non-physician modified endovascular prostheses at the investigational site
• Willing to travel to an investigational site with access to a non-physician modified endovascular prosthesis
• Unwilling or unable to comply with the follow-up schedule
• Inability or refusal to give informed consent by patient or legal representative
• Patient is pregnant or breastfeeding
• Life expectancy < 2-years despite successful aneurysm exclusion
• Free rupture with hemodynamic instability
• Ongoing infection
• Diagnosis of, or suspected connective tissue disease
• Known sensitivities or allergies to the materials of construction of the devices
• Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
• Uncorrectable coagulopathy
• Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
• Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair
• Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
• Systemic or local infection that may increase the risk of endovascular graft infection
• Leaking or free rupture of aneurysm associated with hemodynamic instability.
• Baseline creatinine greater than 3.0 mg/dL
• Known history of, or suspected connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)

Anatomical exclusion criteria:

• Inadequate femoral or iliac access compatible with the required delivery systems, not amenable to open surgical or endovascular conduit placement
• Absence of a non-aneurysmal aortic segment for proximal seal zone with:

• A diameter measured outer wall to outer wall of no greater than 38mm and no less than 21 mm;
• Parallel aortic wall with <20% diameter change and without significant calcification and/or thrombus in the selected area of seal zone
• Visceral vessel anatomy not compatible with physician-modified Zenith® Alpha Endovascular Graft due to excessive occlusive disease or small size not amenable to stent graft placement
• Unsuitable distal iliac artery fixation site and anatomy:

• Common iliac artery fixation site diameter measured outer wall to outer wall on a sectional image (CT) <8.0 mm with inability to perform open surgical conduit
• Iliac artery diameter measured outer wall to outer wall on a sectional image (CT) >21 mm at distal fixation site, with inability to perform open internal iliac artery revascularization or iliac branch stent graft
• Iliac artery distal fixation site <10 mm in length
• Inability to preserve at least one hypogastric artery