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EKOS Corporation Supports the Dutch Randomized Trial Comparing Standard Catheter-Directed Thrombolysis vs. Ultrasound-Accelerated Thrombolysis for Thrombo-Embolic Infra-Inguinal Disease (DUET).

EKOS Corporation announced 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.

Source: EKOS Corporation

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