January 19, 2010 – Final planning is in progress for a study of ultrasound-accelerated thrombolysis to treat pulmonary embolisms – the ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism (ULTIMA) Study.
The randomized clinical study will be run by Dr. Nils Kucher, University Hospital, Bern, Switzerland. He will be joined by colleagues from the University Hospitals in Dresden, Munich and Greifswald, Germany, and several other sites. The study will use the EKOS EkoSonic Endovascular Device. Enrollment is expected to start in the first quarter of 2010 and be completed by the first quarter of 2011.
“This study is, to our knowledge, the first randomized controlled trial designed to show the clinical benefit of an endovascular device to treat acute sub massive pulmonary embolism in comparison to anti-coagulation therapy alone,” said Dr. Kucher. “We intend to show that treatment with low-dose, ultrasound accelerated thrombolysis [EKOS] will rapidly improve right heart failure in these patients, without introducing the risks typically associated with systemic thrombolytic therapy.”
Current treatments typically involve aggressive anti-coagulation, or in the most serious cases, intravenous delivery of clot dissolving, thrombolytic agents. Anti-coagulants do not dissolve the embolism, but can reduce the mortality rate. Thrombolytics actively dissolve the embolus, but are associated with an increased risk of bleeding. Neither therapy completely dissolves the embolus in all patients, leaving some patients with a chronic clot.
In the previous ULTIMA study, 50 patients with pulmonary embolism and enlarged right hearts will be randomized to receive either standard of care anti-coagulation or Actilyse (Boehringer Ingleheim) delivered via the EKOS EkoSonic Endovascular Device. The amount of drug necessary to dissolve a blood clot is significantly reduced when using the EKOS system because ultrasound increases the permeability of the clot while gently driving the drug into its interior.
For more information: www.ekoscorp.com