Customized endovascular repair for complex aortic aneurysms

MAIN COHORT

INCLUSION CRITERIA:

* A participant may be entered into the study if the participant has at least one of the following: An aneurysm with a maximum diameter of \> 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e, perpendicular to the centerline) measurements; Aneurysm with a history of growth \> 0.5 cm in 6 months; Saccular aneurysm deemed at significant risk for rupture; Symptomatic aneurysm; Ruptured aneurysm

AND

* Extent of aorta to be treated: juxtarenal, pararenal that include 1 or 2 renal and/or accessory renal arteries, paravisceral that includes celiac artery and/or superior mesenteric artery, and/or thoracoabdominal
* High risk of morbidity and mortality with open surgical repair as defined by:

  a. Anatomic Criteria (Previous abdominal surgery; Previous thoracotomy; Previous aortic surgery) b. Physiologic Criteria (ASA Category III or higher; Age \>70 years; Previous myocardial infarction, coronary artery disease, or coronary artery stent; Coronary stress test with a reversible perfusion defect; Congestive heart failure (CHF); Chronic obstructive pulmonary disease (COPD))
* Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
* Nonaneurysmal aortic segment proximal to the aneurysm (neck) with a minimum neck length of 25 mm (Diameter in the range of 18 mm - 42 mm; Angle less than 60o relative to the axis of the aneurysm; Angle less than 60o relative to the axis of the suprarenal aorta);

  * Minimum branch vessel diameter greater than 5 mm
  * Iliac artery distal fixation site greater than 20 mm in length and diameter in the range of 9 mm - 21 mm (for use of ZFEN)
  * Contralateral iliac artery distal fixation site greater than 20 mm in length and diameter in the range of 7.5 mm - 20 mm.
  * Age: ≥ 18 years old
  * Life expectancy: \> 2 years

EXCLUSION CRITERIA:

GENERAL EXCLUSION CRITERIA:

* Able to be treated in accordance with the instructions for use with a currently marketed endovascular prosthesis
* Unwilling to comply with the follow-up schedule
* Inability or refusal to give informed consent by subject or legal representative
* Pregnant or breastfeeding
* Prefers to receive treatment at another hospital with access to a non-physician modified endovascular prosthesis
* Refusal of blood transfusions for religious or personal reasons
* Participation in another investigational clinical or device trial, with the exception of another investigational endovascular stent-graft protocol or percutaneous aortic valve protocol, not encompassed by the IDE protocol and 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.
* Mycotic aneurysm or evidence of active systemic infection

MEDICAL EXCLUSION CRITERIA:

* Known sensitivities or allergies to the materials of construction of the devices, including nitinol (nickel, titanium), polyester, polypropylene, gold, stainless steel, and/or solder (tin, silver).
* Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
* Uncorrectable coagulopathy
* Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment

  • Morbid obesity (BMI ≥ 40 or BMI 30-39.9 with comorbidities)
* Major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \< 30 days of the endovascular repair
* Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
* Baseline creatinine greater than 2.0 mg/dL
* History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)
* Deemed a high risk due to significant comorbidities, adjudicated by severity according to the Society for Vascular Surgery reporting standards for endovascular aortic repair involving the renal-mesenteric arteries

ANATOMICAL EXCLUSION CRITERIA:

* Thrombus or excessive calcification within the neck of the aneurysm
* Presence of significant thrombus and/or excessive calcification within the intended proximal or distal seal zone of the aneurysm.
* Branch stenosis \> 75% (if left untreated)
* Anatomy that would not allow maintenance of at least one patent hypogastric artery

  * Inadequate femoral or iliac access to accommodate the required delivery systems.
  * Requirement for iliac conduit in cases of inadequate femoral/iliac access
  * Absence of a suitable non-aneurysmal segment of distal thoracic aorta and significant aortic tortuosity.
  * Target vessel anatomy not compatible with fenestrated or branched stent graft incorporation, including vessels with severe stenosis, tortuosity and/or insufficient size to accommodate stent graft placement.
  * Early target vessel bifurcation precluding safe or effective stent graft placement.
  * Unsuitable iliac artery fixation site and/or anatomy for iliac limb extension or iliac branch device placement, as defined by the device instructions for use

Note: Patients with life-threatening aortic disease who have no acceptable surgical or endovascular alternatives will be allowed to receive treatment under this IDE in the non-statistical cohort

Non-statistical Cohort

This cohort will include patients who meet the inclusion criteria and meet any of the above exclusion criteria\* with the exception of the following:

* Able to be treated in accordance with the instructions for use with a currently marketed endovascular prosthesis
* Subject prefers to receive treatment at another hospital with access to a custom-made endovascular prosthesis
* Refusal to give informed consent by the subject or legal representative. Note: Inability to consent prior to surgery will not be exclusionary if it is for life-saving measures.
* Known sensitivities or allergies to the materials of construction of the devices will be allowed in a life-threatening situation where the patient would not survive open surgery.