Trial Compares Catheter vs. Ultrasound-Accelerated Thrombolysis
January 15, 2010 – A Dutch multicenter trial (DUET) is comparing ultrasound (US) accelerated catheter-directed thrombolysis to standard catheter-directed thrombolysis in patients with recently thrombosed infra-inguinal native arteries or bypass grafts.
Principle investigator Dr. Jean-Paul de Vries, St. Antonius Hospital, Nieuwegein, said the current therapy of using catheters to deliver thrombolytics to dissolve a clot is time consuming and uncomfortable for the patient. “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,” he said. “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”.
The study will use the EKOS ultrasound accelerated thrombolysis catheter system, which is expected to significantly reduce therapy time by at least 12 hours and help reduce complication rates.
The study includes 60 adult patients with recently (between one and seven 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). They will be randomly allocated to either standard thrombolysis or 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.
The study is being supported by EKOS Corp. and its Netherlands distributor AngioCare BV.
For more information: www.ekoscorp.com