Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic Aneurysms: an Investigator-Initiated Study
An investigator-initiated, prospective, consecutively enrolling, non-randomized single institution clinical evaluation of the safety and effectiveness of branched and fenestrated-branched endovascular stent grafts to preserve branch vessels when used in the treatment of patients with thoraco-abdominal aortic aneurysms. The study evaluates non-FDA-approved off the shelf and custom made branched and fenestrated-branched stent grafts manufactured by Cook Medical. The primary objectives of this study are to determine whether fenestrated-branched and branched endovascular grafts are a safe and effective method of treating patients with thoraco-abdominal aortic aneurysms.
∙ 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 is considered by the treating physician to be at high risk of open surgical repair due to one or more major medical co-morbidities (i.e. CAD, CHF, COPD, CRI, advanced age, generalized deconditioning, or other.) with ASA of 3 or more.
• The patient has a life expectancy of greater than 1 year.
• The patient has a thoraco-abdominal aortic aneurysm where necessary visceral branch vessels (i.e. the celiac, superior mesenteric, inferior mesenteric, renal and/or dominant spinal arteries) arise from the aneurysm or seal zones necessary for on-label thoracic endovascular repair
• Patient has a thoraco-abdominal aortic aneurysm that meets at least one of the following:
‣ aneurysm \> 5.5 cm in diameter
⁃ aneurysm has increased in size by 0.5 cm in last 6 months
⁃ aneurysm is believed to be causing symptoms
• Patient has sufficient arterial access (femoral and/or iliac) that will allow delivery of the endovascular device with or without the use of a surgical conduit.
• Patient has suitable proximal (aorta) and distal (aorta or iliac) arteries to allow for adequate fixation and seal:
∙ A. Non-aneurysmal proximal aortic seal zone:
• with a length of 25 mm of proximal seal in non-aneurysmal aorta, with or without coverage of the left subclavian artery,
• with an outer wall diameter of no less than 20 mm and no greater 38mm, and
• B. Non-aneurysmal distal aortic or iliac landing zone:
• With a length of at least 15 mm,
• Aortic seal zone no less than 15 mm and no greater than 38 mm or Iliac seal zone with an outer wall diameter of no less than 8 mm and no greater than 23 mm.
∙ 10\. The patient has no more than 5 necessary visceral arteries that require flow preservation.
∙ 11\. All target visceral artery seal zones are \> 4 mm in diameter. 12. Patient must be willing to comply with all required follow-up exams.