EKOS Corporation announced today that EKOS and their Netherlands distributor, AngioCare BV, are supporting a Dutch multicentre randomized trial (DUET) designed to compare ultrasound (US) accelerated catheter directed thrombolysis to standard catheter directed thrombolysis in patients with recently thrombosed infra-inguinal native arteries or bypass grafts.
Participating Dutch investigators include: Drs. Jeal-Paul de Vries and A.M. Schrijver (St. Antonius Hospital, Nieuwegein). Additional study sites in the Netherlands are being added.
Robert W. Hubert, President/CEO, said, "We are pleased to support this most important study. The hypothesis is that EKOS ultrasound accelerated thrombolysis will significantly reduce (by at least 12 hours) therapy time compared to standard thrombolysis alone without increasing complication rate."
The study is conducted in accordance with the principles of the Declaration of Helsinki and "good clinical practice". (The study protocol was approved on October 13th, 2009, by the Ethics Committee of the St. Antonius Hospital Nieuwegein. Written informed consent will be obtained prior to randomization.
A total of 60 adult patients with recently (between 1 and 7 weeks) thrombosed infra-inguinal native arteries or bypass grafts with acute limb ischemia class I and IIa, (according to the Rutherford classification for acute ischemia), will be randomly allocated to either group A (standard thrombolysis) or group B (EKOS ultrasound accelerated thrombolysis). The anticipated duration of recruitment will be one year.
The primary endpoint is the duration of catheter directed thrombolysis needed for uninterrupted flow in the thrombosed infra-inguinal native artery or bypass graft with outflow via at least one crural artery.
Principle investigator Dr. Jean-Paul de Vries said, "Arteries occluded by blood clots, mainly due to ruptured vulnerable plaques, are a common serious consequence of advanced peripheral vascular disease. Current therapy involves navigating a plastic tube, called a catheter, via a leg artery into the occluded section where clot dissolving drugs, called thrombolytics, re-liquefy the clot, eliminating the occlusion and re-establishing blood flow. The problem is that this process can take more than 36-48 hours during which the patient is restricted to a bed in a hospital monitoring unit and bleeding complications increase with duration of thrombolysis. This new ultrasound accelerated technology promises to significantly reduce the treatment time. Such a reduction, if proven, could reduce treatment costs, patient discomfort, and the risk of bleeding, which is sometimes associated with these types of drugs."
About EKOS Corporation: EKOS Corporation pioneered the development and clinical application of ultrasonic accelerated drug delivery in medicine, introducing its first system for the treatment of vascular thrombosis in 2005. Today, interventional radiologists, cardiologists and vascular surgeons at leading institutions around the world use the EKOS EkoSonic® Endovascular System to provide faster, safer and more complete dissolution of thrombus. In 2008, the company introduced its 2nd generation EkoSonic® Endovascular System with Rapid Pulse™ Modulation, and in 2009 introduced the MACH4e upgrade. The EkoSonic System is FDA-cleared for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. It is currently used to treat patients with peripheral arterial occlusions (PAO) and deep vein thrombosis (DVT), and additional applications are being investigated. EKOS is currently participating in the ATTRACT trial as a supplier of one of the devices permitted for use. Visit www.ekoscorp.com.
About Angiocare BV: AngioCare BV is considered the leading independent distributor in the Netherlands focusing on diagnostic and interventional therapeutic solutions in the fields of Cardiology, Radiology, Vascular Surgery and Neuroradiology.
Contacts:
PTM Healthcare Marketing, Inc.
Pauline T. Mayer, 631-979-3780
PTM@ptmhcm.com