CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft

General Inclusion Criteria:

• Thoracoabdominal aortic aneurysm with a diameter ≥ 5.5 cm or 2 times the normalaortic diameter.

• Aneurysm with a history of growth ≥ 0.5 cm per year.

• Saccular aneurysms deemed at significant risk for rupture based upon physicianinterpretation.

• Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of theabove-mentioned criteria.

• Presence of thoracoabdominal aortic aneurysm meeting one of the above-mentionedcriteria with unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.0-cm or saccular morphology with no suitable landing zone proximal to iliacbifurcation.

General 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 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.

• 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 (> 30days). Examples include remote (>30 days) participation in a thoracic, abdominal oriliac branch 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.

• Patients with ruptured aortic aneurysms requiring urgent or emergent repair, withthe exception of patients with contained, stable ruptures with anatomy suitable foran off-the-shelf design.

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

• Leaking or ruptured aneurysm associated with hypotension

• Uncorrectable coagulopathy

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

• History of connective tissue disorder (e.g vascular Ehlers Danlos, Marfanssyndrome), with the exception of those patients who had prior open surgical aorticreplacement, where a surgical graft would serve as landing zone for theinvestigational stent-graft, those who are deemed prohibitive risk for open surgicalrepair or connective tissue disorders with no effect of vascular system (e.gnon-vascular forms of Ehlers Danlos).

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

Anatomical 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. A diameter measured outer wall to outer wall of nogreater than 42mm and no less than 21 mm; b. Parallel aortic wall with <20% diameterchange and without significant calcification and/or thrombus in the selected area ofseal zone

• Visceral vessel anatomy not compatible with Zenith t-Branch or patient-specificstent-graft due to excessive occlusive disease or small size not amenable to stentgraft placement

• Unsuitable distal iliac artery fixation site and anatomy for iliac limb extension oriliac branch device: a. Common iliac artery fixation site diameter, measured outerwall to outer wall on a sectional image (CT) <8.0 mm with inability to perform opensurgical conduit ; b. Iliac artery diameter, measured outer wall to outer wall on asectional image (CT) >20 mm at distal fixation site, with inability to perform openinternal iliac artery revascularization or iliac branch stent graft ; c.Non-aneurysmal external liac artery distal fixation site <10 mm in length ; d.Non-aneurysmal internal iliac artery main trunk or branch segment with length <10mmor with inner wall diameter <4 or >14mm; e. Unsuitable anatomy due to inability topreserve at least one hypogastric artery

Additional anatomical inclusion criteria for aortic arch devices:

• Proximal aortic fixation zone: a. Native aorta or surgical graft; b. Diameter: 20-42mm; c. Proximal neck length ≥ 20mm; d. Ascending aortic length ≥50mm; e. Mustoccur distal to coronary arteries and any coronary artery bypass grafts that areconsidered patent and necessary for proper cardiac perfusion

• Distal aortic fixation zone:; a. Native aorta or surgical graft; b. Diameter: 20-42mm; c. Distal neck length ≥20mm

• Supra-aortic trunk (brachiocephalic) vessels: a. Although the prosthesis willtypically have two branches, modifications to the design will allow for a singlebranch, three branches or combination of branch and scallop if a customized versionis required. Thus, it is generally planned that at least one extra-anatomic bypassgraft will be done in conjunction (or in a staged fashion) with the procedure,unless three branches are planned. The two vessels incorporated into the endograftrepair would most commonly be the innominate artery and left common carotid artery.However, the innominate artery may be coupled with the left subclavian artery in thesetting of a bovine arch whereby the flow to the left carotid would come from a leftsubclavian to carotid bypass. Similarly, the left carotid and subclavian artery maybe branched, or simply one vessel branched should specific anatomic limitationsexist. In such a situation, multiple extra-anatomic bypasses may be necessary. Adesign with a single subclavian retrograde branch and double scallop to the leftcarotid artery may be used to extent the landing zone to Zone 1. Finally, a designwith two antegrade inner branches for the innominate and left common carotid, andone retrograde inner branch for the left subclavian artery may be used in selectcases. Thus the inclusion criteria are defined for each artery, yet any combinationof arteries may be used for a repair: Innominate artery (Native vessel or surgicalgraft, Diameter: 8-22mm, Length of sealing zone ≥10mm, Acceptable tortuosity); Left (or right) common carotid artery (Native vessel or surgical graft, Diameter 6-16mm,Length of sealing zone ≥10mm, Acceptable tortuosity); Left (or right) common carotidartery (Native vessel or surgical graft, Diameter: 5-20mm, Length of sealing zone ≥10mm, Acceptable tortuosity).

• In the setting of an aortic dissection the following criteria must exist: a. Accessinto the true lumen from the groin and at least one supra-aortic trunk vessel; b. Asealing zone in the target aorta (or surgical graft) that is proximal to the primarydissection, such that a stent-graft would be anticipated to seal off the dissectionlumen; c. A sealing zone in the target supra-aortic trunk vessels that is distal tothe dissection, anticipated to seal off the dissection lumen, or surgically created;d. A true lumen size large enough to deploy the device and still gain access intothe target branches

• In the setting of more distal disease: a. The repair may be coupled with athoracoabdominal branched device, infrarenal device, and/or internal iliac branchdevice.

• Iliac anatomy must allow for the delivery of the arch branch device which is loadedwithin a 20F-24F sheath. Thus the iliac requirements are no different than thestandard thoracic protocol. Conduits to the iliac vessels or aorta may be used ifdeemed necessary.