Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysm: an Investigator Initiated Study
The primary objectives of this study are to determine whether physician modified endovascular grafts (PMEG) and specified company manufactured devices (all to be referred throughout jointly as the investigational devices) are a safe and effective method of treating patients with elective, symptomatic or ruptured juxtarenal aortic aneurysms in those patients considered to be unsuitable candidates for open surgical repair and have limited or no other options for treatment. Secondary objectives include the validation of a patient-specific, 3-D printed aortic template as a surgical planning tool for fenestrated endografting.
∙ All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:
• Patient is \> 18 years of age
• Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
• Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
• Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:
‣ Abdominal aortic aneurysm \>5.5 cm in diameter
⁃ Aneurysm has increased in size by 0.5 cm in last 6 months.
⁃ Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment
• Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified endovascular graft.
• Patient has a suitable non-aneurysmal proximal aortic neck length of \> 2 mm inferior to the most distal renal artery ostium.
• Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of \>15 mm. The resultant repair should preserve patency in at least one hypogastric artery.
• Patient has a suitable non-aneurysmal proximal aortic neck diameter between 20 and 32mm, averaged across the diameters at the Celiac, SMA, at the lowest patent renal artery and at the midpoint of the renal arteries.
• Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.
⁃ Patient has juxtarenal aortic neck angulation \< 60º
⁃ Patient must be willing to comply with all required follow-up exam-