Study Evaluating the Safety and Performance of the Indigo Aspiration System for Removing Blood Clots in Lower Limb Arteries in Adults

What this Trial Is About

Researchers are evaluating the safety and performance of the Indigo Aspiration System in patients with lower extremity acute limb ischemia LE ALI, a condition involving sudden blockage of blood flow in the lower limbs. The study aims to collect clinical evidence to support the use of this device in removing blood clots causing the ischemia. This observational study focuses on patients diagnosed with LE ALI and assesses the devices impact on limb salvage and other clinical outcomes. Participants will undergo treatment using the Indigo Aspiration System, which involves mechanical aspiration thrombectomy to remove the thrombus. The study includes patients with confirmed arterial occlusion in the lower limb, using the device as the first-line treatment. The intervention is delivered with computer-assisted vacuum thrombectomy aspiration tubing during the procedure. During the study, participants will be monitored for outcomes such as target limb salvage rate at 30 days post-procedure, technical success immediately after the procedure, and primary vessel patency at 30 days. Researchers will also track device-related adverse events including bleeding, distal embolization, serious adverse events, and mortality up to 180 days post-procedure. Participants will be involved in follow-up assessments to evaluate these outcomes and safety measures over time.

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