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

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.