Marlborough, Mass.–based Boston Scientific’s HI-PEITHO trial, a collaborative research study with the Pulmonary Embolism Response Team (PERT) Consortium and the University Medical Center of the Johannes Gutenberg University of Mainz, will compare EkoSonic in combination with anticoagulation to anticoagulation alone for treating acute, intermediate-high-risk pulmonary embolism (PE).
According to a news release, EKOS uses ultrasound energy combined with the thrombolytic drug to dissolve blood clots and restore blood flow in patients with PE and peripheral arterial occlusions. EKOS’ ultrasound technology accelerates thrombolysis by minimizing the time it takes to treat a patient and lowering the necessary thrombolytic dose, which can lower the risk of bleeding.
The randomized HI-PEITHO trial will enroll up to 544 patients with confirmed acute, intermediate-high-risk PE across as many as 65 sites in the U.S. and Europe. Over one year, the trial will assess whether EKOS treatment in combination with anticoagulation is associated with a significant reduction in adverse events compared to anticoagulation alone within seven days of randomization.
Boston Scientific said the composite primary endpoint is defined as PE-related mortality, cardiorespiratory decompensation or collapse and non-fatal symptomatic and objectively confirmed recurrence of PE.
“This first-of-its-kind international randomized controlled trial is intended to address current gaps in clinical guidelines and underscores our support of the highest level of research that may enable physicians to make data-based clinical decisions when choosing the best therapy for their patients with PE,” CMO & VP of clinical affairs, technology & innovation in Boston Scientific’s peripheral interventions segment Dr. Michael R. Jaff said in the release.
