Clinical Outcomes and Major Adverse Events in Patients Treated With Physician-Modified Fenestrated and Branched Stent Grafts

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 percutaneousdrainage)

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

• Arm 1 (Short neck infrarenal, juxtarenal, suprarenal and extent IV TAA)

• Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aortic aneurysmor dissection with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.

• Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aneurysm with ahistory of growth ≥ 0.5 cm in one year.

• Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal saccularaneurysms deemed at significant risk for rupture based upon physicianinterpretation.

• Presence of juxtarenal, pararenal, suprarenal or extent IV thoracoabdominalaortic aneurysm not meeting one of the above-mentioned criteria with or withoutunilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.5-cm orsaccular morphology with no suitable landing zone proximal to iliacbifurcation.

• Arm 2 (Thoracoabdominal aortic aneurysms)

• Extent I, II, or III thoracoabdominal aortic aneurysm or dissection with adiameter ≥ 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 atsignificant risk for rupture based upon physician interpretation.

• Presence of Extent I, II, or III thoracoabdominal aortic aneurysm not meetingone of the above-mentioned criteria with or without unilateral or bilateralcommon iliac artery aneurysm with diameter ≥ 3.5-cm or saccular morphology withno suitable landing zone proximal to iliac bifurcation.

• Arm 3 (Urgent or emergent aneurysms) o Ruptured, contained ruptured or symptomaticjuxtarenal, pararenal, suprarenal or thoracoabdominal aortic aneurysm planned toreceive urgent or emergent repair within 48 hours of clinical encounter, in patientsable to provide informed consent and deemed not a reasonable candidate for opensurgery or repair with any commercially available device.

Exclusion Criteria:

Patients must be excluded from the study if any of the following conditions are true:

• 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 authorizedrepresentative

• Pregnant or breastfeeding

• Life expectancy < 2-years

• Prior open surgical or interventional procedure within 30 days of the anticipateddate of the fenestrated-branched procedure, with the exception of planned stagedprocedures to provide access for repair (e.g. staged iliac conduit, cervicaldebranching, elephant trunk repair), to facilitate the procedure by allowing openrevascularization of a target artery not amenable to revascularization with theinvestigational device, such as an internal iliac artery, subclavian artery orvisceral artery with early bifurcation, tortuosity or occlusive disease preventingsuccessful placement of alignment side stents.

• Patients eligible for treatment with any FDA-approved marketed device within itsinstructions for use

• Can enroll in a manufacturer-sponsored clinical study at our institution or iswilling and eligible to participate in a study with a manufactured-made device atanother institution

• Participation in another investigational clinical or device trial, with theexception of participation in another investigational endovascular stent-graftprotocol, percutaneous aortic valve protocol, or concomitant clinical trialsdesigned to evaluate medical therapy strategies to reduce perioperative risk duringfenestrated-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 ofthese devices. Participation in investigational device trials not encompassed by theIDE protocol should be performed remotely from the fenestrated procedure (>30 days).Examples include remote (>30 days) participation in a thoracic, abdominal, or iliacbranch device trial, or participation in a percutaneous aortic valve trial.Participation in medical therapy trial or advanced imaging trial designed to improveperi-operative outcomes or to reduce radiation exposure of fenestrated-branchedendografts may be concurrent with the IDE study. Examples include therapy directedto reduce rates of spinal cord injury, stroke and contrast-induced nephropathyassociated with implantation of fenestrated-branched stent-grafts or advancedimaging trials designed to reduce radiation exposure during repair.

Medical Exclusion Criteria:

• Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, PTFE, urethane, or gold.

• History of anaphylactic reaction to contrast material that cannot be adequatelypre-medicated.

• Uncorrectable coagulopathy.

• Mycotic aneurysm or patients with evidence of active systemic infection.

• History of connective tissue disorder (e.g vascular Ehlers Danlos, Marfan'ssyndrome), except for those patients who had prior open surgical aortic replacement,where a surgical graft would serve as landing zone for the investigationalstent-graft, those who are deemed prohibitive risk for open surgical repair orconnective tissue disorders with no effect of vascular system (e.g non-vascularEhlers Danlos).

• Body habitus that would inhibit X-ray visualization of the aorta and its branches.

Anatomic Exclusion Criteria

• Inadequate femoral or iliac access compatible with the required delivery systems.

• Inability to perform a temporary or permanent open surgical or endovascular iliacconduit for patients with inadequate femoral/iliac access.

• Absence of a non-aneurysmal aortic segment in the distal thoracic aorta above thediaphragmatic hiatus with:

• A diameter measured outer wall to outer wall of no greater than 42mm and noless than 21 mm;

• Parallel aortic wall with <20% diameter change and without significantcalcification and/or thrombus in the selected area of seal zone

• Visceral vessel anatomy not compatible with fenestrated/branched stent graftvisceral vessel incorporation due to excessive occlusive disease or small size notamenable to stent graft placement

• Unsuitable distal iliac artery fixation site and anatomy for iliac limb extension oriliac branch device as per devices' instructions for use (IFU)