A prospective, non-randomized, multi-center clinical study to evaluate the safety and effectiveness of the Aptus Endovascular AAA Repair System compared to an open surgical repair historical control group in the treatment of abdominal aortic aneurysms (AAA).
The historical group is the open surgical repair procedures (n=323) in the Lifeline Foundation (now American Vascular Association Foundation).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
155
EVAR (endovascular aneurysm repair)
The Vascular Group
Albany, New York, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Effectiveness: Composite Success Rate
Composite endpoint of delivery success, absence of Type I/III endoleak requiring intervention post-index procedure, absence of migration (\>10mm), and absence of aneurysm rupture or conversion.This composite endpoint is compared to an estimated success rate of 80%.
Time frame: 12 months
Safety: MAE (Major Adverse Event)
Percentage (number) of subjects experiencing one or more of major adverse events within the first 30 days post-index procedure compared to the open surgical repair historical group
Time frame: 30 days
Safety: SAE (Serious Adverse Event)
Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure
Time frame: 5 years
Effectiveness: Surgical Conversion
Percent (number) of subjects undergoing surgical conversion through 12 months post-index procedure. Conversion is defined as the patient undergoing open surgical aneurysm repair with partial or complete removal of the study device.
Time frame: 12 months
Effectiveness: Aneurysm Rupture
Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure
Time frame: 12 months
Effectiveness: Aneurysm Change
Percent (number) of subjets experiencing aneurysm change (defined as increase in maximum diameter of \>5mm) at 12 months post-index procedure
Time frame: 12 months
Effectiveness: EndoStaple Stent/Fracture
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Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure
Time frame: 12 months
Effectiveness: Prosthesis Migration
Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure
Time frame: 12 months
Effectiveness: Type I Endoleak and Type III Endoleak
Percent (number) of subjects experiencing type I endoleak (inadequate or ineffective seal of graft) or III endoleak (inadequate seal of graft joints or graft rupture) requiring intervention through 12 months post-index procedure
Time frame: 12 months
Effectiveness: Thrombosis
Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure
Time frame: 5 years