New study will assess EkoSonic in patients with chronic DVT, post-thrombotic syndrome

EKOS Corporation announced the start of patient enrollment for the ACCESS PTS study, which will assess the safety and efficacy of ultrasound-accelerated thrombolysis in patients with chronic deep vein thrombosis and post-thrombotic syndrome.

The prospective, multicenter, single-arm trial is designed to evaluate the EkoSonic Endovascular System in up to 200 patients during a 12-month period across 30 US sites. Clinical follow-up will be performed at 12 months, according to a press release.

The device’s efficacy will be measured according to the Villalta score, an indicator of post-thrombotic syndrome severity, at 12 months compared with baseline. A 4-point or greater reduction in Villalta score, which indicates significant improvement in post-thrombotic syndrome symptoms, in at least half of the participants will be considered success.

Eligible participants are aged 18 to 75 years. All participants will have lower-extremity deep vein thrombosis diagnosed as persistent for 6 months or longer, a Villalta score of 8 or higher, demonstrated failure to respond to 3 months of treatment with conservative therapies such as anticoagulants and compression stockings.

“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,” principal investigator Mark Garcia, MD, medical director at the Center for Comprehensive Venous Health at Christiana Care in Newark, Del., said in the release.