Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

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

Summary: The purpose of this study is to assess the use of off-the-shelf and custom made devices (CMDs) for the endovascular repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms in standard and high-risk patients having appropriate anatomy. The study consists of two cohorts. The first cohort is the continuation of the current IDE study, aimed to assess the use of custom made devices (CMDs) for the endovascular repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms in standard and high-risk patients having appropriate anatomy (Fenestrated -CMD cohort). The second cohort (Type I-III thoracoabdominal cohort) include patients with type I- III thoracoabdominal aneurysms that require the use of branched/fenestrated CMDs , or, in selected cases, the Zenith Thoracoabdominal Branch (Zenith® t-Branch™) device.

Detailed description: This study is a prospective, single center, non-randomized, double-cohort study. For the Fenestrated-CMD cohort a total of 150 patients will be enrolled. For the type I-III thoracoabdominal cohort, a total of 100 patients will be enrolled. CMDs will be used primarily. Off-the-shelf devices will be used in urgent cases and when the waiting period for design and manufacturing of a CMD may not be considered acceptable. Staged endovascular repair will be used for type I, II and III TAAAs, unless the condition of the patient requires a single stage endovascular repair. A separate subgroup analysis of patients undergoing procedures with off-the-shelf devices will be performed.

Eligibility: General Inclusion Criteria A patient is deemed suitable for inclusion in the study if the patient has at least one the following:
  1. Juxtarenal or suprarenal AAA and type I-IV thoracoabdominal aortic aneurysms with diameter ≥5.0 cm in diameter or 2 times the normal aortic diameter;
  2. Aneurysm with history of growth ≥0.5 cm/year;
  3. Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation.
  4. Patients that are not eligible for treatment with commercially available endografts.
  General Exclusion 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, breast-feeding, 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, with the exception of planned staged procedures to provide access for repair (e.g. staged iliac conduit, thoracic endovascular aortic aneurysm repair for proximal aneurysms), 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, with the exception of observational studies or participation in another investigational endovascular endograft protocol or percutaneous aortic valve protocol, not encompassed by the IDE protocol (>30 days).
  8. Patients with ruptured aortic aneurysm requiring urgent or emergent repair. Medical Exclusion Criteria
  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 premedicated
  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's syndrome), with the exception of 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.
  7. Body habitus that would inhibit x-ray visualization of the aorta and its branches.
  Anatomical Exclusion Criteria
  Patient must be excluded from the study if any of the following is true:
  1. Inadequate femoral or iliac access compatible with the requirements of the required delivery system.
  2. Thoracic aortic aneurysms that extend into the arch, with the exception of those patients who had prior open surgical aortic replacement or endovascular repair, where a surgical graft or an endograft has been extended proximal and/or near the celiac artery (functional type IV) that would serve as landing zone for the investigational endograft.
  3. Inability to perform a temporary or permanent open surgical or endovascular iliac conduit for patients with inadequate femoral/iliac access.
  4. Absence of a landing aortic segment in the distal thoracic aorta above the diaphragmatic hiatus with:
  1. A diameter measured outer to the outer wall greater than 38 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.
  5. Visceral anatomy not compatible with the investigational device due to excessive occlusive disease or small size not amenable to stent graft placement.
  6. 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 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.

Relevance to patient case: not relevant