The Pivotal Study of the Aptus Endovascular AAA Repair System

Study Overview
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Brief Summary
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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).

Detailed Description
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The historical group is the open surgical repair procedures (n=323) in the Lifeline Foundation (now American Vascular Association Foundation).

Official Title
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The Pivotal Study of the Aptus Endovascular AAA Repair System

Conditions
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Abdominal Aortic Aneurysms (AAA)

Intervention / Treatment
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* Device: Aptus Endovascular AAA Repair System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infrarenal AAA with a maximum diameter ≥ 4.5 cm. Infrarenal AAA with at least 12 mm length of non-aneurysmal proximal neck. Infrarenal AAA with a proximal neck internal diameter between 19-29 mm. Infrarenal AAA with an internal diameter at the aortic bifurcation ≥ 18 mm. Infrarenal AAA with an angle of ≤ 60° relative to the long axis of the aneurysm. Bilateral iliac artery distal fixation sites ≥ 10 mm in length. Bilateral iliac arteries with an internal diameter between 9 and 20 mm. Bilateral femoral/iliac arteries with morphology compatible with standard vascular access techniques and vessel size must accommodate a 16F (5.3 mm) or 18F (6.0 mm) delivery system. Exclusion Criteria: Myocardial infarction within past 10 weeks. Active systemic infection. Ruptured or leaking AAA. Mycotic or inflammatory AAA. Genetic connective tissue disorders (e.g., Marfans or Ehlers-Danlos Syndromes). Concomitant TAA or thoracoabdominal aortic aneurysms. Requires emergent AAA surgery. Previous AAA repair. Patients with a body habitus that would prevent imaging required by the study. Patient has significant comorbid conditions that pose undue risk of general anesthesia or endovascular surgery. Patient requires additional planned major procedure at the time of AAA repair or within 30 days before or after AAA repair. Dialysis dependent renal failure or creatinine > 2.5 mg/dL. Allergy to or intolerance of radiopaque contrast agents. Patients with a known sensitivity or allergy to implant materials. Patients who cannot discontinue oral anticoagulation or antiplatelet therapy at the time of the study procedure. Patients with history of bleeding diathesis or hypercoagulable condition. Patients with thrombus, calcification, and/or plaque ≥ 2mm in thickness and/or ≥ 50% (180°) continuous coverage of the vessel circumference in the intended seal zone. Patients with irregular shaped calcification and/or plaque that may compromise the fixation and sealing at the proximal or distal implantation sites.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AAA Repair System<br> | Device: Aptus Endovascular AAA Repair System<br>* EVAR (endovascular aneurysm repair)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%. | 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 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: SAE (Serious Adverse Event) | Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure | 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. | 12 months | 
| Effectiveness: Aneurysm Rupture | Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure | 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 | 12 months | 
| Effectiveness: EndoStaple Stent/Fracture | Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure | 12 months | 
| Effectiveness: Prosthesis Migration | Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure | 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 | 12 months | 
| Effectiveness: Thrombosis | Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure | 5 years |