EKOS initiates a pivotal new study in patients with chronic deep vein thrombosis and post-thrombotic syndrome
EKOS Corporation, a BTG International group company (BTG plc; LSE: BTG), today announces the start of patient enrollment for the ACCelerated ThrombolySiS for Post-Thrombotic Syndrome using the EKOS System (ACCESS PTS) Study.
Deep Vein Thrombosis (DVT) is a common medical condition affecting 600,000 people annually in the United States. The most common complication of DVT is Post-Thrombotic Syndrome (PTS), which can affect from 25% to 60% of individuals suffering DVT.2 Despite traditional anticoagulation and elastic compression stocking therapy, a significant proportion of DVT becomes chronic with post-thrombotic sequelae which impose significant limitations to a patient's quality of life.
The ACCESS PTS study is a prospective, single-arm, multi-center trial, designed to evaluate the safety and efficacy of ultrasound accelerated thrombolysis using the EkoSonic(r) Endovascular System with standard infusion of a thrombolytic drug for PTS and chronic venous occlusions. The study will enroll 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-EkoSonic(r) treatment. 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 PTS.
Mark Garcia, MD, Medical Director, Center for Comprehensive Venous Health at Christiana Care in Newark, DE 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 DVT, but also give hope to all those suffering from PTS while significantly improving their quality of life."
Matt Stupfel, General Manager at EKOS Corporation, also commented, "We are pleased to announce that the ACCESS PTS study is open for patient enrollment. We hope this study will demonstrate that new and innovative technologies like the EkoSonic(r) Endovascular System can effectively treat these patients in cases where traditional exercise, anticoagulation drugs and compression stockings have been deemed inadequate."
Potential study subjects 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
· A Villalta score ≥8.
· Failed 3 months of conservative treatment including compression stockings and anticoagulation drugs
If you are a physician treating a patient that meets the study criteria, please email ekosclinical@ekoscorp.com to learn more about the study and whether or not your patient may qualify.