Ekos Initiates Pivotal ACCESS PTS Study

June 11, 2014—Ekos Corporation, a BTG International group company, announced the start of patient enrollment for a pivotal study in patients with chronic deep vein thrombosis (DVT) and postthrombotic syndrome (PTS). The ACCESS PTS (Accelerated Thrombolysis for Post-Thrombotic Syndrome Using the Ekos System) study is a prospective, single-arm, multicenter 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 PTS and chronic venous occlusions. 

According to Ekos, the study will enroll up to 200 patients over a period of 12 months at approximately 30 study sites across the United States. Patients will receive clinical follow-up for 12 months. Clinical effectiveness will be evaluated using the Villalta score (a measurement of the severity of PTS) at baseline compared to 30 days posttreatment with the EkoSonic device. Success will be defined by 50% or more of the patients achieving at least a 4-point reduction in the Villalta score, which represents a significant improvement in PTS symptoms.

Mark Garcia, MD, Medical Director of the Center for Comprehensive Venous Health at Christiana Care in Newark, Delaware, is the Lead Investigator of the study. In the Ekos press release, Dr. Garcia stated, “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 DVT, but also give hope to all those suffering from PTS while significantly improving their quality of life.”

The company advised that potential study patients will be between 18 and 75 years of age with lower extremity DVT who have been objectively diagnosed via imaging as having persistent DVT for at least 6 months, have a Villalta score ≥ 8, and have failed with 3 months of conservative treatment including compression stockings and anticoagulation drugs.
 
Additional information about ACCESS PTS is available on the Ekos website at www.ekoscorp.com/healthcare_professionals.htm. Physicians interested in learning more about the study and determining if their patients are eligible for enrollment are invited to contact the company at ekosclinical@ekoscorp.com.