Jan. 18, 2010 14:30 UTC
BOTHELL, Wash.--(BUSINESS WIRE)--
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.
