Clinical Outcomes and Quality of Life Measures in Patients Treated for Thoracoabdominal Aortic Aneurysms With Fenestrated and Branched Stent Grafts
Trial status: Open for Enrollment
Why is this study being done?
This is a traditional device feasibility study intended to generate preliminary safety and efficacy information that may be used to plan an appropriate future study, or to inform further product development.
The study is a prospective, non-randomized, non-blinded, single-arm, single-center study.
The purpose of this study is to evaluate clinical outcomes and quality of life measures in a consecutive cohort of patients treated by endovascular aortic repair of thoracoabdominal aortic aneurysms (types I to IV) using a Zenith t-Branch or a customized physician-specified stent-graft with a combination of fenestrations and/or branches.
Who is eligible to participate?
General Inclusion Criteria:
1. Thoracoabdominal aortic aneurysm with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.
2. Aneurysm with a history of growth ≥ 0.5 cm per year.
3. Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.
General Exclusion Criteria:
1. Less than 18 years of age
2. Unwilling to comply with the follow-up schedule
3. Inability or refusal to give informed consent by the patient or a legally authorized representative
4. Pregnant or breastfeeding
5. Life expectancy < 2 years
6. Prior open surgical or interventional procedure within 30 days of the anticipated date of the fenestrated-branched procedure, with the exception of planned staged procedures to provide access for repair (e.g., staged iliac conduit, cervical debranching), to facilitate the procedure by allowing open revascularization of a target artery not amenable to revascularization with the investigational device, such as an internal iliac artery, subclavian artery or visceral artery with early bifurcation, tortuosity or occlusive disease preventing successful placement of alignment side stents.
7. Participation in another investigational clinical or device trial, with the exception of participation in 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.
8. Patients with ruptured aortic aneurysms requiring urgent or emergent repair, with the exception of patients with contained, stable ruptures with anatomy suitable for an off-the-shelf design.
Medical Exclusion Criteria:
1. Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, polytetrafluoroethylene (PTFE), 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, Marfans syndrome), with the exception of those patients who had prior open surgical aortic replacement, where a surgical graft would serve as landing zone for the investigational stent-graft.
7. Body habitus that would inhibit X-ray visualization of the aorta and its branches.
Anatomical Exclusion Criteria:
1. Inadequate femoral or iliac access compatible with the required delivery systems.
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 non-aneurysmal aortic segment in the distal thoracic aorta above the diaphragmatic hiatus with:
1. A diameter measured outer wall to outer wall of no greater than 38mm and no less than 21 mm;
2. Parallel aortic wall with <20% diameter change and without significant calcification and/or thrombus in the selected area of seal zone
4. Visceral vessel anatomy not compatible with Zenith t-Branch or physician-specified stent-graft due to excessive occlusive disease or small size not amenable to stent graft placement
5. Unsuitable distal iliac artery fixation site and anatomy:
1. Common iliac artery fixation site diameter, measured outer wall to outer wall on a sectional image (CT) <8.0 mm with inability to perform open 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
3. Iliac artery distal fixation site <10 mm in length
4. Inability to preserve at least one hypogastric artery