Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms (AAA)

Inclusion Criteria:

• Patient has signed and understood the approved Informed Consent form and is able tomeet the proposed study proceedings (CIP).

• Patient is ≥18 years of age

• Need for standard or complex EVAR of AAA according to the relevant guidelines:

• Asymptomatic aneurysms with a diameter > 55mm in men and > 50 mm in woman

• Aneurysm-growth exceeds 10mm/year

• Patient requires at least one cannulation during which requires at least onecannulation (e.g. fenestration of endograft, side-branch and/or contralateral leg ofendograft)

Exclusion Criteria:

• Patient is generally contraindicated for EVAR

• Patient requires an emergency surgery

• Patient with an increased risk of aneurysm rupture or saccular aneurysm, aneurysm withisolated wall protuberances or penetrating aortic ulcer

• Patient with a dissecting acutely ruptured or leaking aneurysm or an acute vascularinjury caused by a trauma

• Patient with stroke or transient ischemic attack (TIA) within the last 6 months priorto baseline

• Patient with myocardial infarction (MI) with the last 3 months prior to baseline

• Patient with acute or chronic renal failure (including dialysis); Creatinine > 2.00mg/dl or > 182 µmol/L

• Patient with co-morbidities that constitutes an unacceptable risk (for example chronicobstructive pulmonary disease (COPD), liver failure, immunosuppression, polyneuropathyand hematological diseases)

• Patient with bleeding history or coagulopathy

• Patient with contraindication or allergies to take anticoagulants, antiplatelet drugsor contrast media

• Life expectancy of less than 5 years

• Female patient that is pregnant, is planning on becoming pregnant in the next month oris breastfeeding

• Patient with inability to obtain vascular access

• Patient has an active local or systemic infection

• Patient is currently participating in another investigational study where theendpoints have not yet been achieved

• Patient has a mental illness, and/or been diagnosed as clinically depressed or belongsto a vulnerable population (e.g., prisoner, severe drug abuser, developmentallydisabled) that would compromise the ability to provide informed consent.

• Patient has an obstructed or inadequate vasculature by means of tortuous anatomyhindering the TC catheter to reach target orifice(s)

• Patient has an elevated risk of plaque dislodgment.