A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)

Inclusion Criteria: * Age ≥18 years * Patients with a confirmed diagnosis of lower limb arterial occlusion located in the common iliac or below, with a minimum of 2 cm of proximal patency in the common iliac * Acute occlusion with symptom duration of 14 days or less at presentation * ALI Rutherford Category I, IIa or IIb * First-line treatment with the Indigo Aspiration System using Computer Assisted Vacuum Thrombectomy (CAVT) aspiration tubing * Informed consent is obtained from either patient or legally authorized representative (LAR) per Institutional Review Board/Ethics Committee requirements * Previously enrolled patients presenting with a new acute occlusion in the contralateral limb meeting all eligibility criteria may be re-enrolled if the new acute occlusion is greater than 30 days from the initial index procedure Exclusion Criteria: * Life expectancy \<1 year * Target vessel size \<2 mm * Target thrombus is in the aorta or isolated profunda artery * Prior major amputation (proximal to the tarsometatarsal joint) in the target limb * Prior minor amputation in the target limb within the past 6 months that is not completely healed or cannot bear weight * LE ALI secondary to dissection, vasculitis, or target vessel trauma, including iatrogenic etiology from treatment of a proximal location in the target limb, and non-thrombotic material such as tumor fragments, fat emboli, septic emboli, and foreign bodies * Target thrombus in a vein bypass graft, previously revised b…