EKOS Corporation has announced the start of patient enrolment for the Accelerated thrombolysis for post-thrombotic syndrome using the EkoSonic endovascular system (ACCESS PTS) study.
The ACCESS PTS study is a prospective, single-arm, multicentre trial, 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. The study will enrol up to 200 subjects over a period of 12 months at approximately 30 study sites across the United States. Subjects will receive clinical follow-up for 12 months.
Clinical effectiveness will be evaluated using the Villalta score (measurement of the severity of PTS) at baseline compared to 30 days post-EkoSonictreatment. Success will be defined by 50% or more of the subjects achieving at least a 4 point reduction in the Villalta score, which represents a significant improvement in the symptoms of post-thrombotic syndrome.
Mark Garcia, medical director, Center for Comprehensive Venous Health at Christiana Care in Newark, USA, and the lead investigator of the study states, “This is an incredibly exciting time as we embark on a truly landmark trial that may not only alter the way physicians treat patients with chronic deep vein thrombosis, but also give hope to all those suffering from post-thrombotic syndrome while significantly improving their quality of life.”
Potential study subjects will be between 18 and 75 years of age with lower extremity deep vein thrombosis who have:
- Been objectively diagnosed via imaging as having persistent deep vein thrombosis for at least six months
- A Villalta score ≥8.
- Failed three months of conservative treatment including compression stockings and anticoagulation drugs.