Duke Customized Aortic Aneurysm Repair With Endovascular Stent-grafts - Duke CARES Trial

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.