Abdominal Aortic Aneurysm Clinical Trial
Official title:
Prospective, Open-label, Multicenter, Non-randomized Clinical Study to Determine the Safety and Efficacy of SETA LATECBA Stent Graft for Endovascular Repair Therapy (EVAR) in Subjects With Abdominal Aortic Aneurysm (AAA).
This is a Prospective, Open-label, Multicenter, and Non-randomized Clinical Study. The main purpose of this study is to establish the efficacy and safety of a medical device system, SETA LATECBA Stent Graft, intended for the treatment of EVAR of pararenal AAA (patients with complex anatomy, not eligible for other surgical procedure).Other objective is to evaluate the technical performance of the device SETA LATECBA Stent Graft.
This is a Prospective, Open-label, Multicenter, and Non-randomized Clinical Study to
determine the Safety and Efficacy of the SETA LATECBA Stent Graft for endovascular repair
therapy (EVAR) in Subjects with Abdominal Aortic Aneurysm (AAA)..The main purpose of this
study is to establish the efficacy and safety of a medical device system, SETA LATECBA Stent
Graft, intended for the treatment of Endovascular Aneurysm Repair (EVAR) of pararenal AAA
(patients with complex anatomy, not eligible for other surgical procedure).
Secondary objective(s): The secondary objective is to evaluate the technical performance of
the device SETA. LATECBA Stent Graft which includes: access to the implantation site,
visualization, deployment of the stent- graft, sizing compatibility, withdrawal of the
delivery system, and compatibility with ancillary equipment.
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