To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
Dijklander Ziekenhuis
Hoorn, North Holland, Netherlands
ETZ Elisabeth
Tilburg, Tilburg, Netherlands
Incidence of related major adverse events (MAEs)
Incidence of related major adverse events (MAEs)
Time frame: 30 days post-procedure
Efficacy - Technical Success
Technical success, defined as filling of the residual flow lumen of the AAA sac with investigational products
Time frame: Immediately after the intervention
Incidence of related major adverse events (MAEs)
Incidence of related major adverse events (MAEs)
Time frame: 5 years post-procedure
Incidence of related serious adverse events (SAEs)
Incidence of related serious adverse events (SAEs)
Time frame: 5 years post-procedure
Efficacy - Type II endoleaks
Incidence of type II endoleaks
Time frame: 5 years post-procedure
Efficacy - Type I and type III endoleaks
Incidence of type I and type III endoleaks
Time frame: 5 years post-procedure
Efficacy - AAA sac diameter/volume
Change in AAA sac diameter/volume
Time frame: 5 years post-procedure
Efficacy - Open repair
Rate of conversion to open AAA repair
Time frame: 5 years post-procedure
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Efficacy - Reinterventions
Rate of other reinterventions related to the AAA sac growth and/or complications
Time frame: 5 years post-procedure