Clinical Outcomes and Radiation Safety After Endovascular Repair of Complex AAAs Using Fenestrated- Branched Devices

Exclusion Criteria

• •5. Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria.
• •A patient must be excluded from the clinical investigation if any of the following are true:
• •1. Age \<18 years
• •2. Life expectancy \<2 years
• •3. Pregnant, breastfeeding, or planning on becoming pregnant within 60 months;
• •4. Inability or refusal to give informed consent by the patient or a legally authorized representative;
• •5. Unwilling or unable to comply with the follow-up schedule
• •6. Prior surgical or interventional procedure within 30 days of the anticipated date of the fenestrated procedure, except for planned staged procedures to provide access for repair (e.g. staged iliac conduit, thoracic endovascular aortic aneurysm repair for proximal aneurysms, elephant trunk repair), to facilitate the procedure by allowing open reparation of a target artery not amenable to revascularization with the investigational device, such us an internal iliac artery, subclavian artery or visceral artery with early bifurcation, tortuosity or occlusive disease preventing successful placement and alignment side stents, or to treat proximal aortic aneurysms.
• •7. Participation in another clinical or device trial, except observational studies, participation in another investigational endovascular endograft protocol, percutaneous aortic valve protocol, or concomitant clinical trials designed to evaluate medical therapy strategies to reduce perioperative risk during fenestrated-branched endovascular repair, including risks of renal dysfunction, contrast-induced nephropathy, neurologic, spinal cord or cardiac complications, and/or use of advanced imaging to reduce radiation exposure during implantation of these devices. Participation in investigational device trials not encompassed by the IDE protocol should be performed remotely from the fenestrated/branched repair (\>30 days). Participation in a medical therapy trial or advanced imaging trial designed to improve peri-operative outcomes or to reduce radiation exposure of fenestrated/branched endografts may be concurrent with the IDE study. Examples include therapy directed to reduce rates of spinal cord injury, stroke, and contrast-induced nephropathy associated with implantation of fenestrated-branched stent-grafts or advanced imaging trials designed to reduce radiation exposure during repair.
• •8. Patients with ruptured aortic aneurysm requiring urgent or emergent repair, except patients with contained, stable ruptures with anatomy suitable for an off-the-shelf design.
• •9. Patients who meet anatomical criteria for commercially available aortic stent-grafts according to the proposed instructions for use of these devices.
• •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 pre-medicated
• •3. Leaking or ruptured aneurysm associated with hypotension
• •4. Uncorrectable coagulopathy
• •5. Mycotic aneurysm or patients with evidence of active systemic infection.
• •6. History of connective tissue disorder (e.g. vascular Ehlers Danlos, Marfan syndrome), except those patients who had prior open surgical aortic replacement or endovascular repair, where a surgical graft or an endograft would serve as landing zone for the investigational endograft, those who are deemed prohibitive risk for open repair or connective tissue disorders with no vascular effects (e.g. non-vascular types of Ehlers Danlos).
• •7. Body habitus that would inhibit x-ray visualization of the aorta and its branches.
• •Patient must be excluded from the study if any of the following are true:
• •1. Inadequate femoral or iliac access compatible with the requirements of the required delivery system.
• •2. Inability to perform a temporary or permanent open surgical or endovascular iliac conduit for patients with inadequate femoral/iliac access.
• •3. Absence of a landing aortic segment in the distal thoracic aorta above the diaphragmatic hiatus with:
• •1. A diameter measured from the outer wall greater than 42 mm or less than 19 mm
• •2. Parallel aortic wall with \>20% diameter change and with significant calcification and/or thrombus in the selected area of the seal zone.
• •4. Visceral anatomy not compatible with the investigational device due to excessive occlusive disease or small size not amenable to stent graft placement.
• •5. Unsuitable distal iliac arterial fixation site and anatomy:
• •1. Common iliac artery fixation site diameter measured outer wall to outer wall on a section image (CT)\< 8.0 mm, with inability to perform surgical conduit.
• •2. Iliac artery diameter measured outer wall to outer wall on a sectional image (CT) \> 21 mm at the distal fixation site, with inability to perform open internal iliac artery revascularization or iliac branch stent graft or custom iliac extension with fenestration.
• •3. Iliac artery distal fixation site \<10 mm in length.
• •4. Inability to preserve at least one hypogastric artery.
• •For patients in the type I-III TAAA cohort, the intended use criteria are the same for both the fenestrated/branched CMD vs the off-the-shelf device. The CMD will preferably be used, unless an urgent repair is indicated or the waiting period for design or manufacturing of the CMD is considered unacceptable.