iSchemaView today announced that the company’s RAPID imaging platform has been chosen for use in determining subject eligibility for the “Thrombolysis in imaging eligible late window patients (4.5-24 hours) to evaluate the efficacy and safety of tenecteplase,” TIMELESS trial, which will evaluate the efficacy and safety of tenecteplase compared with placebo in patients with late window acute ischemic stroke (AIS). Genentech, a member of the Roche Group, sponsored the study.
Stroke is the third leading cause of death and primary cause of long-term disability in the United States. Acute ischemic strokes (AIS) account for 87 percent of all strokes. An ischemic stroke occurs when an obstruction, like a blood clot, blocks blood flow to the brain.
The TIMELESS trial is designed to evaluate whether tenecteplase is safe and effective for use in AIS when administered between 4.5 and 24 hours after stroke onset.
“Advanced imaging with RAPID was instrumental in changing the AHA guidelines for thrombectomy (mechanical reperfusion) and has the potential to be equally impactful for thrombolysis (chemical reperfusion),” said Mikayel Grigoryan, M.D., Medical Director of Neurointervention at Adventist Health Glendale Comprehensive Stroke Center.
Unique in the comprehensive depth and range of its clinical validation, RAPID is now also the imaging standard in stroke research. iSchemaView’s imaging solution now has a research footprint across more than 300 stroke centers, more than 10 large-scale international clinical trials, and is being used clinically in over 800 hospitals worldwide. RAPID has been shown to aid in the selection of patients in early and late-window stroke trials, including SWIFT PRIME, EXTEND IA, DAWN, DEFUSE 3 and EXTEND, and has been granted FDA clearance for selection of patients for both early and late window thrombectomy.
“The choice of iSchemaView for the TIMELESS study makes it clear: RAPID is the de facto standard for clinical trials in stroke,” said Carolina Maier, PhD, Vice President of Research at iSchemaView. “RAPID is the only imaging technology for stroke that has been clinically validated, which is why it has been used in such a broad range of clinical trials and why it is used in over 1,000 stroke centers worldwide.”