EKOS has initiated patient enrollment in the ACCESS PTS study, designed to evaluate the safety and efficacy of ultrasound accelerated thrombolysis using the EkoSonic endovascular system with standard infusion of a thrombolytic drug for post-thrombotic syndrome and chronic venous occlusions.
ACCESS PTS is a single-arm study that will enroll up to 200 patients at approximately 30 study sites in the US over a period of 12 months. Potential study subjects will be between 18 and 75 years of age with lower extremity deep vein thrombosis and will receive clinical follow-up for 12 months.
Clinical effectiveness will be assessed using the Villalta score (measurement of the severity of PTS) at baseline compared to 30 days post-EkoSonic treatment.
According to EKOS, success will be defined by 50% or more of the subjects achieving at least a four point reduction in the Villalta score, which represents a significant improvement in the symptoms of post-thrombotic syndrome.
EKOS general manager Matt Stupfel said that the company hopes this study will demonstrate that new and innovative technologies like the EkoSonic endovascular system can effectively treat these patients in cases where traditional exercise, anticoagulation drugs and compression stockings have been deemed inadequate.