Cerevast Therapeutics, a US-based medical technology firm, has begun enrolling patients for the Phase III clinical trial to evaluate the use of Clotbust ER ultrasonic headframe, which is meant for the treatment of acute ischemic stroke.
The randomised, double-blinded clinical trial is being conducted at more than 60 stroke centres in 14 countries worldwide and is aimed at evaluating the safety of the ultrasound device when used along with regular intravenous thrombolytic therapy (tissue plasminogen activator - tPA/Alteplase).
The device has been designed to non-invasively deliver therapeutic ultrasound energy to the occluded brain vessel.
For the study, the company intends to enrol up to 800 ischemic stroke patients with baseline National Institute of Health Stroke Scale (NIHSS) scores of ten or more.
During the trial, patients will be randomly selected to either Clotbust ER ultrasound in combination with IV tPA therapy or regular IV tPA therapy alone.
The company claimed that the primary endpoint of the study is 90-day functional outcome as calculated by the percentage of patients that achieve a modified Rankin (mRS) score of 0-1 at 90 days after the treatment.
For the secondary endpoint, the study will evaluate complete vessel recanalisation in a subset of patients who undergo pre and post-treatment MRI or CT angiography.
Following the completion of one and two thirds of patient enrollment, two interim analyses will be performed by the study's Data Safety Monitoring Board (DSMB).
Every year around 795,000 strokes occur in the US and stroke is considered to be the third leading cause of death in the country.
Currently, tPA is the only FDA approved treatment for ischemic stroke.
Clotbust ER study steering committee chairman Dr Carlos Molina said that the medical community is eager to obtain access to new technologies to improve the outcomes of patients that are affected by the serious effects of ischemic stroke.
"There have been very few treatment advances since tPA was originally approved in the US in 1996.
"If validated in this Phase 3 clinical study, the Clotbust ERTM will serve as a major advancement in stroke care, providing clinicians with a new and novel treatment option to improve the clinical outcomes of stroke patients worldwide," Molina added.
The Clotbust ER also received European CE mark clearance in December 2011.