| Eligibility |
General Inclusion Criteria:
- 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.
- Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of the
above-mentioned criteria.
- Presence of thoracoabdominal aortic aneurysm meeting one of the above-mentioned
criteria with unilateral or bilateral common iliac artery aneurysm with diameter =
3.0-cm or saccular morphology with no suitable landing zone proximal to iliac
bifurcation.
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 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.
- 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
peri-operative 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.
- Patients with ruptured aortic aneurysms requiring urgent or emergent repair, with the
exception of patients with contained, stable ruptures with anatomy suitable for an
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 adequately
pre-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, Marfans syndrome),
with the exception of those patients who had prior open surgical aortic replacement,
where a surgical graft would serve as landing zone for the investigational
stent-graft, those who are deemed prohibitive risk for open surgical repair or
connective tissue disorders with no effect of vascular system (e.g non-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 iliac
conduit for patients with inadequate femoral/iliac access.
- Absence of a non-aneurysmal aortic segment in the distal thoracic aorta above the
diaphragmatic hiatus with: a. A diameter measured outer wall to outer wall of no
greater than 42mm and no less than 21 mm; b. 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 Zenith t-Branch or patient-specific
stent-graft due to excessive occlusive disease or small size not amenable to stent
graft placement
- Unsuitable distal iliac artery fixation site and anatomy for iliac limb extension or
iliac branch device: a. 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 ; b. Iliac artery diameter, measured outer wall to outer wall on a
sectional image (CT) >20 mm at distal fixation site, with inability to perform open
internal 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 <10mm or
with inner wall diameter <4 or >14mm; e. Unsuitable anatomy due to inability to
preserve 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. Must
occur distal to coronary arteries and any coronary artery bypass grafts that are
considered 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 will
typically have two branches, modifications to the design will allow for a single
branch, three branches or combination of branch and scallop if a customized version is
required. Thus, it is generally planned that at least one extra-anatomic bypass graft
will be done in conjunction (or in a staged fashion) with the procedure, unless three
branches are planned. The two vessels incorporated into the endograft repair 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 the setting of a
bovine arch whereby the flow to the left carotid would come from a left subclavian to
carotid bypass. Similarly, the left carotid and subclavian artery may be branched, or
simply one vessel branched should specific anatomic limitations exist. In such a
situation, multiple extra-anatomic bypasses may be necessary. A design with a single
subclavian retrograde branch and double scallop to the left carotid artery may be used
to extent the landing zone to Zone 1. Finally, a design with two antegrade inner
branches for the innominate and left common carotid, and one retrograde inner branch
for the left subclavian artery may be used in select cases. Thus the inclusion
criteria are defined for each artery, yet any combination of arteries may be used for
a repair: Innominate artery (Native vessel or surgical graft, 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 carotid artery (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. Access
into the true lumen from the groin and at least one supra-aortic trunk vessel; b. A
sealing zone in the target aorta (or surgical graft) that is proximal to the primary
dissection, such that a stent-graft would be anticipated to seal off the dissection
lumen; c. A sealing zone in the target supra-aortic trunk vessels that is distal to
the 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 into the
target branches
- In the setting of more distal disease: a. The repair may be coupled with a
thoracoabdominal branched device, infrarenal device, and/or internal iliac branch
device.
- Iliac anatomy must allow for the delivery of the arch branch device which is loaded
within a 20F-24F sheath. Thus the iliac requirements are no different than the
standard thoracic protocol. Conduits to the iliac vessels or aorta may be used if
deemed necessary.
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