Inclusion Criteria:

A patient may be included in the study if at least one of the following is present and is considered appropriate for treatment with a physician modified stent graft.

Patients must be deemed high risk for traditional open surgical repair, if any of the following conditions are present. Patients will be deemed physiologically high risk if any of the following conditions are present:

• Older than 75 years of age
• Chronic obstructive pulmonary disease
• Congestive heart failure
• Previous myocardial infarction, coronary stent, or bypass
• Chronic renal insufficiency with baseline eGFR < 40 ml/min
• American Society of Anesthesiologist (ASA) score > 3

Patient will be deemed anatomically high risk if any of the following conditions are present:

• Prior intraabdominal operation(s)
• Prior abdominal wall reconstructions. (ie. Ventral hernia repairs)
• Prior radiation therapy targeting abdomen and/or pelvis
• History of intraabdominal sepsis. (ie. Diverticulitis managed with percutaneous drainage)

Patients will then be included in one of three arms with the inclusion criteria specified as follows:

Arm 1

• Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aortic aneurysm or dissection with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.
• Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aneurysm with a history of growth ≥ 0.5 cm in one year.
• Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.
• Presence of juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aortic aneurysm not meeting one of the above-mentioned criteria with or without unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.5-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation.

Arm 2

• Extent I, II, or III thoracoabdominal aortic aneurysm or dissection with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.
• Extent I, II, or III thoracoabdominal aortic aneurysm with a history of growth ≥ 0.5 cm in one year.
• Extent I, II, or III thoracoabdominal saccular aortic aneurysms deemed at significant risk for rupture based upon physician interpretation.
• Presence of Extent I, II, or III thoracoabdominal aortic aneurysm not meeting one of the above-mentioned criteria with or without unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.5-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation.

Arm 3

• Ruptured, contained ruptured or symptomatic juxtarenal, pararenal, suprarenal or thoracoabdominal aortic aneurysm planned to receive urgent or emergent repair within 48 hours of clinical encounter, in patients able to provide informed consent and deemed not a reasonable candidate for open surgery or repair with any commercially available device.

Exclusion Criteria:

• Less than 18 years of age
• Unwilling to comply with the follow-up schedule
• Inability or refusal to give informed consent by the patient or a legally authorized representative
• Pregnant or breastfeeding
• Life expectancy < 2-years
• Prior open surgical or interventional procedure within 30 days of the anticipated date of the fenestrated-branched procedure, with the exception of planned staged procedures to provide access for repair (e.g. staged iliac conduit, cervical debranching, elephant trunk repair), to facilitate the procedure by allowing open revascularization of a target artery not amenable to revascularization with the investigational device, such as an internal iliac artery, subclavian artery or visceral artery with early bifurcation, tortuosity or occlusive disease preventing successful placement of alignment side stents.
• Patients eligible for treatment with any FDA-approved marketed device within its instructions for use
• Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufactured-made device at another institution
• Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol, percutaneous aortic valve protocol, or concomitant clinical trials designed to evaluate medical therapy strategies to reduce perioperative risk during fenestrated-branched endovascular repair, including risks of renal dysfunction, contrast-induced nephropathy, neurologic, spinal cord or cardiac complications, and/or use of advanced imaging to reduce radiation exposure during implantation of these devices. Participation in investigational device trials not encompassed by the IDE protocol should be performed remotely from the fenestrated procedure ( > 30 days). Examples include remote  (> 30 days) participation in a thoracic, abdominal, or iliac branch device trial, or participation in a percutaneous aortic valve trial. Participation in medical therapy trial or advanced imaging trial designed to improve perioperative outcomes or to reduce radiation exposure of fenestrated-branched endografts may be concurrent with the IDE study. Examples include therapy directed to reduce rates of spinal cord injury, stroke and contrast-induced nephropathy associated with implantation of fenestrated-branched stent-grafts or advanced imaging trials designed to reduce radiation exposure during repair.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/24/2024. Questions regarding updates should be directed to the study team contact.