Mark J. Garcia, M.D., FSIR, medical director of the Center for Comprehensive Venous Health at Christiana Care, is lead investigator of a nationwide research study evaluating the use of guided ultrasound and medication for patients suffering from post-thrombotic syndrome, the most common complication that can result from chronic deep vein thrombosis. The project, called the ACCESS PTS (ACCelerated ThrombolySiS for Post-Thrombotic Syndrome) study, is designed to evaluate the safety and efficacy of treatment consisting of ultrasound using the EKOS Corporation’s EkoSonic® Endovascular System along with a clot-busting drug called recombinant tissue plasminogen activator or r-tPA or Alteplase (Genentech).
Christiana Care’s Center for Heart & Vascular Health is one of approximately 30 participating study sites from across the United States.
The study aims to enroll up to 200 patients over a period of 12 months. Patients receive follow-up care for 12 months.
“We are always looking for innovative treatments that can lead to better outcomes and improve the quality of lives of our patients,” said Dr. Garcia. “This is truly a 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.”
Post-thrombotic syndrome is the most common complication following deep vein thrombosis. Deep vein thrombosis is the formation of a blood clot, known as a thrombus, in the deep leg vein, affecting 600,000 people annually in the United States.
Post-thrombotic syndrome causes damage to the veins from the blood clot. The damage reduces blood flow out of the affected areas that can lead to abnormal pooling of blood in the leg, which can cause leg swelling, chronic leg pain, fatigue, skin discoloration and even venous ulcers. Symptoms may not occur until a few years after the deep vein thrombosis
Currently, treatment options are limited to medication, such as blood thinners, aspirin or diuretics, as well as the use of elastic compression stockings. Even with the use of blood thinners and compression stockings, a significant number of patients with deep vein thrombosis suffer from the syndrome, which can significantly impact quality of life.
The study aims to determine the effectiveness of using catheter-guided ultrasound energy and clot-busting medication with the EkoSonic Endovascular System to treat the affected area, restore blood flow in the previously blocked vein and reduce the degree of post-thrombotic symptoms. Researchers will evaluate the clinical effectiveness of the treatment using the Villalta score (measurement of the severity of post-thrombotic syndrome) at baseline compared to 30 days following treatment as well as increments out to one year. Success will be defined by 50 percent 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.
“We hope 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,” said Matt Stupfel, general manager at EKOS Corporation. Patients eligible to participate must be between 18 and 75 years of age with lower extremity deep vein thrombosis who have:
- Been diagnosed as having persistent deep vein thrombosis for at least six months.
- Have a Villalta score ≥8.
- Failed three months of conservative treatment including compression stockings and blood thinning drugs.
Patients who would like an evaluation for possible participation in the study should call Christiana Care’s Cardiovascular Clinical Trials Program at 302-733-2658.