Medical technology company Boston Scientific has commenced the randomised controlled trial of the EkoSonic endovascular system (EKOS).

The company has collaborated with the Pulmonary Embolism Response Team (PERT) Consortium and the University Medical Center of the Johannes Gutenberg University of Mainz to conduct the research study of the HI-PEITHO clinical trial.

The study will compare the use of the EKOS system in combination with anticoagulation to anticoagulation alone to treat acute and intermediate-high-risk pulmonary embolism (PE).

The trial co-lead principal investigator Dr Kenneth Rosenfield said: “The lead investigators of the trial are pleased to collaborate with the PERT Consortium, which is committed to evidence-driven therapy and is proud to take part in the HI-PEITHO study, aiming to advance the care of patients with PE.”

Boston Scientific will recruit up to 544 patients with confirmed acute and intermediate-high-risk PE in the trial at more than 65 sites in the US and Europe.

During one year follow up, the study will evaluate whether treatment with the EKOS system in combination with anticoagulation is linked with a significant reduction in adverse events compared to anticoagulation alone, within seven days of randomisation.

The composite primary endpoint is determined as PE-related mortality, cardiorespiratory decompensation or collapse and non-fatal symptomatic and objectively confirmed recurrence of PE, said the company.

Boston Scientific chief medical officer and clinical affairs vice president Dr Michael Jaff said: “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.”

The ultrasound energy in combination with a thrombolytic drug is used by the EKOS system for the dissolving of blood clots and restoration of blood flow in patients with PE and peripheral arterial occlusions.

The ultrasound technology used by the EKOS system will help speed up thrombolysis, the breakdown of the clot, to decrease the necessary thrombolytic dose.