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RapidPulse Pivotal Clinical Trial
The pivotal study of RapidPulse® as a frontline approach for patients with acute ischemic stroke due to large vessel occlusions.
Study Objectives
Primary Effectiveness Endpoint
Key Secondary Effectiveness Endpoints
Primary Effectiveness Endpoint
First Pass Reperfusion Effect (FPE) as defined by mTICI ≥ 2c after one reperfusion attempt as assessed by an independent Core lab.
Primary Safety Endpoint
Key Secondary Effectiveness Endpoints
Primary Effectiveness Endpoint
Rate of symptomatic intracranial hemorrhage (sICH) at 24 hours post-thrombectomy as assessed by an independent Clinical Events Committee.
Key Secondary Effectiveness Endpoints
Key Secondary Effectiveness Endpoints
Key Secondary Effectiveness Endpoints
Frontline mTICI ≥ 2b after up to 3 passes (without rescue) as assessed by independent core lab.
90 day modified Rankin Scale (mRS).