Aortic Aneurysm Clinical Trial
Official title:
Evaluation of the Safety and Efficacy of Multiple Overlapping Uncovered Stents for Endovascular Pararenal Aortic Aneurysm Repair
Complex aortic aneurysms involving major branches have been difficult endovascularly. The primary purposes of this study is to evaluate the safety, feasibility, and efficacy of multiple overlapping uncovered stents in treating aortic aneurysm while preserving major visceral branches, including the celiac artery (CA), superior mesenteric artery (SMA) and renal artery (RA).
The traditional endovascular treatment of aneurysms is based on the utilization of
stent-grafts that create a mechanical barrier between the aneurysmal sac and normal blood
flow. Problems such as endoleak and occlusion of collateral arteries impede its application
in complex aneurysms adjacent to or involving vital branches. Advanced branched/fenestrated
endografts have been applied in many experienced centers, but the application of these
techniques is limited in less-experienced centers due to the complicated and cumbersome
nature of these procedures.
The concept of using bare metal stents to occlude aneurysms was firstly described about two
decades ago. Geremia et al suggested that a metallic stent bridging a saccular aneurysm
would alter the local flow pattern, promoting thrombus formation, thereby leading to
aneurysm occlusion. Optimal flow modulation effect is reached with a mean stent porosity of
65%. To achieve such low mesh porosity while maintaining the flexibility of the stent, the
investigators applied multiple stents in an overlapping fashion. Computational simulation in
this study has demonstrated that with 3 or 4 bare metal stents deployed, the mesh porosity
could be decreased to an effective value, slowing flow velocity within the sac. The use of
overlapping stents has been reported in the treatment of peripheral aneurysms with
satisfactory clinical outcome.
The primary purposes of this study is to evaluate the safety, feasibility, and efficacy of
multiple overlapping uncovered stents in treating aortic aneurysm while preserving major
visceral branches, including the celiac artery (CA), superior mesenteric artery (SMA) and
renal artery (RA).
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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