EKOS acknowledges or supports the following research studies which incorporate ultrasound accelerated thrombolysis as a treatment modality. Studies marked as off label (OL) are intended to provide data in support of potential future clinical applications and regulatory submissions.

The ATTRACT Trial (DVT)

Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis. Designed to determine if the initial use of Pharmacomechanical Catheter-Directed Thrombolysis (PCDT) in symptomatic patients with acute upper leg deep vein thrombosis (DVT) reduces the occurrence of Post-Thrombotic Syndrome (PTS) over a 24-month follow-up period. Principal Investigator of this NIH-funded, Phase III, multi-center, randomized, controlled clinical study is Dr.Suresh Vedantham, from Washington University in St. Louis, MO. This is an NIH-funded, Phase III, multi-center, randomized, controlled clinical trial. Patients in the experimental arm will be treated with PCDT and intrathrombus delivery of rt-PA for a period of up to 24 hours followed by standard anti-coagulant DVT therapy. Patients in the control arm will receive only standard anti-coagulant DVT therapy. The study is in the process of initiation at 30-50 centers with the goal of recruiting 692 patients. The protocol is designed to maximize the probability of removing > 90% of the venous clot in the experimental arm patients through the use of PCDT devices and/or standard catheter-directed thrombolysis (CDT). Investigators are allowed to use EKOS ultrasound accelerated thrombolysis as an alternative to standard CDT.

Click here to learn more about the ATTRACT Trial

The CAVA Trial (CAtheter Versus Anticoagulation)

A randomized controlled Dutch multicenter trial comparing ultrasound-accelerated catheter-directed thrombolysis and standard anticoagulant therapy, with standard anticoagulant therapy alone, in acute primary iliofemoral deep vein thrombosis.

Objectives
To assess whether ultrasound-accelerated CDT combined with standard anticoagulant therapy in acute primary IFDVT can significantly reduce the postthrombotic syndrome (PTS) incidence after 1 year compared with standard anticoagulant therapy alone. The secondary objective is to investigate the effects on clot lysis, patency of the affected vein, valve function, recurrent thrombosis rate, HR-QOL and medical costs.

The DUET Trial

Dutch randomized trial comparing standard catheter-directed thrombolysis versus ultrasound-accelerated thrombolysis for thrombo-emoblic infra-inguinal disease (DUET).In the DUET Trial, 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 trial is 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.

Drs. Jean-Paul de Vries and A.M. Schrijver (St. Antonius Hospital, Nieuwegein, NL) and Dr. Michel M.P.J. Reijnen (Rijnstate Hospital, Arnhem, NL)are the Principle Investigators.  Additional study sites in the Netherlands are being added

The ULTIMA Trial (OL)

ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism (ULTIMA). 

In the ULTIMA Trial, 50 patients with pulmonary embolism and enlarged right hearts (RV/LV ratio ≥ 1) will be randomized to receive either standard of care anti-coagulation or Actilyse (Boehringer Ingelheim) delivered via the EKOS EkoSonic Endovascular Device. The trial is designed to confirm that ultrasound accelerated thrombolysis will produce significant reduction in right heart size at 24 hours, compared to anti-coagulant alone, without increased bleeding or other adverse events.

Dr. Nils Kucher at the University Hospital in Bern Switzerland is the Principle Investigator for the study.  Additional study sites are the University Hospitals in Dresden, Munich, Leipzig and Greifswald Germany.

The Interventional Management of Stroke (IMS III) Trial (OL)

The purpose of the IMS III Trial is to compare the safety and efficacy of two different treatment approaches: 1) combined intravenous (IV) and intra-arterial (IA) recombinant tissue plasminogen activator (rt-PA); and 2) standard (IV) rt-PA alone; to restoring blood flow in the brain following acute occlusion of a treatable cerebral artery (ischemic stroke). Treatment must be initiated within three hours of acute ischemic stroke onset. Principal Investigators of this NIH (NINDS) funded randomized, multi-center, controlled study are Drs. Thomas Tomsick and Joseph Broderick of the University of Cincinnati. This is an NIH (NINDS) – funded randomized, multi-center, controlled study. Target enrollment is 900 patients. When patients are randomized to the experimental (IV-IA) arm and are candidates for IA therapy, the investigator can chose among several techniques including IA infusion of rt-PA using the MicroSonic SV Endovascular Device.

Background of the IMS studies
The Interventional Management of Stroke III study is based largely on two preceeding studies called IMS I [ref Broderick] and IMS II [ref Broderick & Tomsick] which evaluated the safety of delivering IA rt-PA in acute ischemic stroke patients. IMS I used exclusively a standard microcatheter for IA delivery. IMS II used the EKOS Microsonic SV Endovascular Device whenever possible; otherwise a standard microcatheter was used. The EkoSonic SV Endovascular System was used in 41% of the patients in the 73 patient trial to deliver the thombolytic drugs directly to the clot.

Click here to learn more about the IMS III Trial

Please note the Intended Use Statements regarding the EkoSonic SV™  Endovascular System

Peripheral Vasculature: The EkoSonic SV Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Neuro Vasculature: The EkoSonic SV Endovascular System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EkoSonic SV Endovascular System may be used for controlled, regional infusion into selected vessels.

Coronary Vasculature: The EkoSonic SV Endovascular System is intended to deliver physician specified fluids to the coronary vasculature.

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