| Eligibility |
Cohort 1 (TAAA) Inclusion Criteria:
Patients may be included in the study if the patient has at least one of the following and
has aortic anatomy appropriate for treatment with the Zenith® p-Branch™, Zenith® t-Branch,
or Physician Specified TAAA Endovascular Graft (Custom Manufactured Devices).
1. Aortic Aneurysm Diameter
a. TAAA (Type I - IV) (including pararenal subtypes) with orthogonal aortic diameter
greater than or equal to 5 cm or b. greater than two times the normal aortic diameter
2. Rapid aortic enlargement (> than or equal to 5mm in 1 year)
3. Presence of a saccular aneurysm at risk for rupture based on investigators evaluation
4. Iliac artery aneurysm ?2.2 cm may be treated with the Zenith® Branch Endovascular
Graft-Iliac Bifurcation when the iliac artery aneurysm is associated with the
qualifying thoracoabdominal aneurysm treated in this study
Exclusion Criteria:
General Exclusion Criteria
Patients must be excluded from the study if any of the following conditions are true:
1. Less than 18 years of age
2. Unwilling to comply with the follow-up schedule
3. Inability or refusal to give informed consent
Medical Exclusion Criteria
Patients must be excluded from the study if any of the following conditions are true:
1) Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin,
silver), polypropylene, urethane or gold 2) History of anaphylactic reaction to contrast
material that cannot be adequately premedicated 3) Leaking, ruptured aneurysm associated
with hypotension 4) Uncorrectable coagulopathy
Anatomical Exclusion Criteria
Patients must be excluded from the study if any of the following conditions are true:
1. Inadequate femoral/iliac access compatible with the required delivery systems;
2. Does not have a non-aneurysmal aortic segment proximal to the aneurysm with:
a. A length of at least 4 mm, i.e. at least 4 mm circumferential wall contact around
the limits of scallop b. A diameter measured outer wall to outer wall of no greater
than 31mm and no less than 21 mm; c. An angle less than 60 degrees relative to the
centerline of the aneurysm; d. An angle less than 45 degrees relative to the
supraceliac aorta.
3. Does not have visceral vessel anatomy compatible with Zenith® p-Branch™, specifically:
a. Renal vessel origins as measured relative to the superior mesenteric artery (SMA)
compatible with the renal fenestration, i.e. Both renal vessel origins within 7.5mm of
the corresponding renal fenestrations; b. Celiac vessel origin as measured relative to
the superior mesenteric artery (SMA) compatible with the celiac scallop.
4. A proximal seal site with unsuitable thrombus/atheroma
5. Does not have iliac artery fixation sites and anatomy consistent with:
1. Common iliac artery fixation site diameter, measured outer wall to outer wall on
a sectional image (CT) <8.0 mm (prior to deployment)
2. Iliac artery diameter, measured outer wall to outer wall on a sectional image
(CT) >21 mm at distal fixation site
3. Iliac artery distal fixation site <10 mm in length
4. Inability to preserve at least one hypogastric artery
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Cohort 2 (ascending/aortic arch) Inclusion Criteria:
General Inclusion Criteria:
1. Treatment not possible with a currently available non-modified approved device
2. Patient accepts to and is able to comply with lifetime follow-up
3. Patient accepts to and is able to provide informed consent prior to enrollment
4. No stroke with significant residual deficit or myocardial infarction within the last
12 months
5. No significant carotid bifurcation disease (> 70% stenosis by NASCET criteria)
6. Absence of systemic or local infection that may increase the risk of endovascular
graft infection
7. Patient determined to be a high-risk profile for open surgical repair considering any
of the following items:
1. Anatomy: previous sternotomy or left-sided thoracotomy (if the proposed open
repair would require dissection of the thoracic aorta), previous aortic surgery,
large aneurysm abutting the sternum with risk of disruption during sternotomy,
prior cervical or chest irradiation.
2. Physiology: ASA Category = III, age >70 years, previous myocardial infarction,
coronary artery disease, or coronary artery stent, coronary stress test with a
reversible perfusion defect, COPD, congestive heart failure
Vascular Inclusion Criteria:
1. Aortic Aneurysm Diameter: Ascending and/or Arch aneurysm with or without aortic or
aortoiliac aneurysm with orthogonal aortic diameter greater than two times the normal
aortic diameter
2. Rapid aortic enlargement (= 5 mm in 1 year)
3. Presence of a saccular aneurysm at risk for rupture based on the investigators
evaluation
4. Clinical indication for aneurysm repair based on symptoms
5. Concomitant thoracoabdominal and aortic arch aneurysm meeting one of the
above-mentioned criteria.
Anatomic Inclusion Criteria:
1) There is enough space for the device to be deployed distal to coronary arteries and any
coronary artery bypass grafts that are considered patent and necessary for proper cardiac
perfusion 2) Ascending aortic length >50 mm (greater curve distance from sinotubular
junction to proximal aspect of the innominate artery) 3) Sealing zone in the ascending
aorta >40 mm in length and <38 mm in diameter for native aorta (<42 mm if surgical graft
replacement in place) 4) Sealing zone in the great vessels of >20 mm in length
- Diameter of innominate artery used for sealing < 20 mm
- Diameter of CCA or subclavian artery used for sealing < 16mm 5. Distal aortic fixation
zone: Native aorta or surgical graft (endovascular device or Dacron graft) , diameter:
20-42mm, distal neck length =20mm 6) Access for device delivery to accommodate 22F or
24F sheath depending on device design.
7) Sealing zone in the great vessels of = 20 mm in length
- Diameter of innominate artery used for sealing between 8 and 20 mm
- Diameter of CCA or subclavian artery used for sealing between 6 and 16 mm.
Extra inclusion criteria - special situations:
- Aortic dissection:
1. A true lumen size large enough for device deployment and to gain access into the
target branches
2. A sealing zone in the target aorta (or surgical graft) that is proximal to the
primary dissection, so that the graft would seal off the dissection lumen
3. A sealing zone in the target supra-aortic trunk vessels that is distal to the
dissection or surgically created
4. Access into the true lumen from the groin and to at least one supra-aortic trunk
vessel
- If more distal disease is observed in the aorta
1. The repair might be coupled with a thoracoabdominal branched device
2. Iliac anatomy large enough to allow the delivery of the arch branch device which
is loaded within a 20F-24F sheath. Iliac conduits may be set in place if
necessary.
Exclusion Criteria:
General exclusion criteria:
1. Life expectancy less than 2 years
2. Less than 18 years of age
3. Women must not be pregnant or breastfeeding
4. Active malignancy with life expectancy less than 2 years
5. Presence of mycotic aneurysm, systemic or local infection in access sites that may
increase the risk of endovascular graft infection
6. Untreatable coagulopathy
7. Coronaropathy / Unstable angina
8. Anaphylactic reaction to contrast that cannot be adequately pre-medicated
9. Cultural objection to receipt of blood or blood products
10. Allergy or sensitivity to the endografts material (stainless steel, polyester,
polypropylene, solder (tin, silver), gold, or nitinol)
11. Leaking or ruptured aneurysm associated with hypotension
12. Participation in another investigational clinical or device trial, except for
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
13. Prior open surgical or interventional procedure within 30 days of the anticipated date
of the fenestrated-branched procedure, with the exception of planned procedures to
provide access for repair (e.g. staged iliac conduit, cervical debranching) or to
facilitate the procedure.
Anatomic Exclusion Criteria for the Cook Ascending/Arch graft
1. Significant occlusive disease, tortuosity, or calcification that would prevent
endovascular access.
2. Iliac artery diameter, measured inner wall to inner wall on a sectional image (CT)
<7.0 mm at any point along access length (prior to deployment). Inability to perform a
temporary or permanent open surgical or endovascular iliac conduit for patients with
inadequate femoral/iliac access.
3. Proximal seal length < 40 mm
4. Proximal seal site with a circumferential thrombus/atheroma/calcium
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