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Clinical Trials Achieving Success from Early to Late Window

Used in the most influential stroke clinical trials around the world, Rapid®-based trials have achieved the best results ever obtained in endovascular stroke studies. View details of trials below.

When Minutes Matter—Fast Delivery of Data Counts

While currently accepted imaging practices for diagnosis of stroke may take one hour to complete, RapidAI software provides automated analysis in less than two minutes. In evidence-based trials, RapidAI imaging technology has given healthcare professionals the data needed to make more informed treatment decisions—often resulting in more accurate care for those with strokes. Extremely fast delivery of data can enable treatment that may be potentially brain-saving or even life-saving for patients.

Clinical Benefits

Clinical Benefits Chart
Proven Clinical Benefits, Best Results Ever Achieved

Since 2015, there have been 10 randomized trials of endovascular therapy for treatment of acute stroke. Four of these trials used RapidAI technology to select optimal patients for enrollment. The trials that used the Rapid platform achieved substantially larger clinical benefits than the other trials. The absolute risk reductions shown here illustrate the difference in the favorable outcome rates in the endovascular arm vs. the medical control arm for each trial. The risk reductions achieved in the Rapid studies are the largest ever achieved in stroke treatment trials.

Early Window Trials

Early Window Trials
Innovative Therapy, Improved Clinical Outcomes

In 2015, a new standard for stroke therapy was established based on five landmark clinical trials. These studies confirmed that blocked blood vessels in stroke patients could be opened by catheter-guided stent retrievers. This innovative therapy, in turn, led to a remarkable improvement in clinical outcomes. The new stent retrievers were typically used in combination with tissue plasminogen activator (tPA). The comparison groups in these new studies typically received standard therapy with tPA alone, which has been the standard of care for stroke therapy for 20 years.

Among the new trials, the Rapid software was used to select patients for enrollment in two studies that achieved the best results in an endovascular stroke study:

  • EXTEND-IA: 71% good outcome rate
  • SWIFT PRIME: 60% good outcome rate

Late Window Trials

DEFUSE 3 Modified Rankin Scale Scores Chart
Groundbreaking Study, New AHA Guidelines

DEFUSE 3 was an NIH-funded study that enrolled stroke patients with favorable Rapid profiles and randomized them to treatment with endovascular thrombectomy vs. standard medical therapy between 6 and 16 hours after stroke onset. The study demonstrated dramatic improvements in stroke outcomes. The main results of the study are shown above. Rapid-selected patients randomized to endovascular thrombectomy had substantially better outcomes on the modified Rankin scale (mRS) 90 days after the stroke. The mRS scores range from 0 to 6, with 0 indicating no symptoms, 1 no clinically significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability, and 6 death. The percentage of patients who were functionally independent, defined as a score on the modified Rankin scale of 0 to 2, at 90 days was 45% in the endovascular-therapy group, as compared with 17% in the medical-therapy group. 

In addition to nearly 3 times as many patients having a favorable outcome from their stroke, the rate of severe disability and death was reduced from 42% to 22%. This represents the largest reduction in unfavorable outcomes ever achieved. Learn More.

DAWN Modified Rankin Scores Chart
Extended Treatment Window to 24 hours

DAWN enrolled stroke patients with favorable RAPID profiles and randomized them to treatment with endovascular thrombectomy vs. standard medical therapy between 6 and 24 hours after stroke onset. The study demonstrated that for these well-selected patients, thrombectomy led to a considerable increase in stroke recovery. The main results of the study are shown above. RAPID- selected patients randomized to endovascular thrombectomy had substantially better outcomes on the modified Rankin scale (mRS) 90 days after the stroke. The mRS scores range from 0 to 6, with 0 indicating no symptoms, 1 no clinically significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability, and 6 death. The percentage of patients who were functionally independent, defined as a score on the modified Rankin scale of 0 to 2, at 90 days was 49% in the endovascular-therapy group, as compared with 13% in the medical-therapy group. This represents the largest increase in favorable outcomes ever achieved in a stroke study.

HERMES / DAWN + DIFUSE 3 Chart
Game-Changing Technology, Shattering Limits

Late window trials with 100% RAPID-selection had larger treatment benefits than the early window trials summarized in the HERMES (Highly Effective Reperfusion Evaluated in Multiple Endovascular Stroke Trials) pooled analysis, p=0.006 for difference in treatment effect. Learn More.