The Clotbust ER Phase III clinical study is being conducted at over 60 leading stroke centers in 14 countries worldwide.
The study intends to enroll up to 800 ischemic stroke patients with baseline National Institute of Health Stroke Scale (NIHSS) scores of ten or greater. The primary endpoint of the study is 90-day functional outcome as measured by the percentage of patients that achieve a modified Rankin (mRS) score of 0-1 at 90 days post-treatment.
The study will evaluate complete vessel recanalization as a secondary endpoint in a subset of patients that undergo pre and post-treatment MRI or CT angiography.
Cerevast Therapeutics is an operator independent device that can be rapidly and easily deployed by virtually any emergency room staff to safely administer the ultrasound energy for SonoLysis therapy.
Cerevast Therapeutics CEO Bradford A Zakes noted the initiation of the Clotbust ER Phase III study represents a significant milestone for the company.
"Clinical data in over 200 subjects has demonstrated that the addition of transcranial ultrasound to conventional IV tPA therapy has a favorable safety profile and results in significant improvements in vessel recanalization and 90-day clinical outcomes in ischemic stroke patients when compared to IV tPA therapy alone," Zakes added.
The Clotbust ER also received European CE mark clearance in December 2011.
