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

This is an interventional treatment trial for Aortic Aneurysm, Abdominal focused on measuring Endovascular aneurysm repair, EVAR, AAA, Cannulation, Blood Flow Velocity Read More

Inclusion Criteria:

• Patient has signed and understood the approved Informed Consent form and is able to meet 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 one cannulation (e.g. fenestration of endograft, side-branch and/or contralateral leg of endograft)

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 with isolated wall protuberances or penetrating aortic ulcer
• Patient with a dissecting acutely ruptured or leaking aneurysm or an acute vascular injury caused by a trauma
• Patient with stroke or transient ischemic attack (TIA) within the last 6 months prior to baseline
• Patient with myocardial infarction (MI) with the last 3 months prior to baseline
• Patient with acute or chronic renal failure (including dialysis); Creatinine > 2.00 mg/dl or > 182 µmol/L
• Patient with co-morbidities that constitutes an unacceptable risk (for example chronic obstructive pulmonary disease (COPD), liver failure, immunosuppression, polyneuropathy and hematological diseases)
• Patient with bleeding history or coagulopathy
• Patient with contraindication or allergies to take anticoagulants, antiplatelet drugs or contrast media
• Life expectancy of less than 5 years
• Female patient that is pregnant, is planning on becoming pregnant in the next month or is 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 the endpoints have not yet been achieved
• Patient has a mental illness, and/or been diagnosed as clinically depressed or belongs to a vulnerable population (e.g., prisoner, severe drug abuser, developmentally disabled) that would compromise the ability to provide informed consent.
• Patient has an obstructed or inadequate vasculature by means of tortuous anatomy hindering the TC catheter to reach target orifice(s)
• Patient has an elevated risk of plaque dislodgment.