INSPIRE-S is a unique large scale, multi-device registry that aims to continuously assess SAFETY and measure EFFECTIVENESS of market released neurovascular products for the treatment of Acute Ischemic Stroke. In addition, the cumulatively collected high volume of patient data drives THERAPY EVIDENCE to support treatment paradigms in the rapidly evolving neurovascular therapy field.

Primary study endpoint is mRS at 90 days. Secondary objectives include CLINICAL EVENTS COMMITTEE adjudicated SAFETY endpoints; independent CORE LABORATORY measured EFFECTIVENESS endpoints; Health Economics outcomes.

INSPIRE-S was launched in May 2020. 1260 patients are planned to be enrolled from approximately 40 neurointerventional centers across the EMEA region. The study is comprised of 3 cohorts based on the first pass mechanical thrombectomy strategy applied:

• Aspiration only first pass
  
• Stent Retriever only first pass
  
• Combined use of Stent Retriever and Aspiration Catheter
  first pass

Interim results of this large-scale platform are regularly shared at various scientific meetings and conferences.

The SWIFT PRIME study compared the functional outcomes
in acute ischemic stroke (AIS) subjects treated with either IV
t-PA alone or IV t-PA in combination with the Solitaire™
revascularization device.

The study was stopped early because of efficacy. 196 patients underwent randomization (98 patients in each group) in 39 sites in the United States and 6 European countries.

In the intervention group, the rate of substantial reperfusion at the end of the procedure was 88%. Thrombectomy with the stent retriever plus intravenous t-PA reduced disability at 90 days over the entire range of scores on the modified Rankin scale (P<0.001).

The rate of functional independence (mRS 0 to 2) was higher in the intervention group than in the control group (60% vs. 35%, P<0.001). There were no significant between-group differences in 90-day mortality (9% vs. 12%, P=0.50) or symptomatic intracranial hemorrhage (0% vs. 3%, P=0.12)

Conclusion:
In patients receiving intravenous t-PA for acute ischemic stroke with confirmed large-vessel occlusions of the anterior circulation, treatment with the Solitaire™ stent thrombectomy device within 6 hours after symptom onset improved functional outcomes at 90 days.