Pulse Endovascular ReperFUSION for Acute Ischemic Stroke
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Prospective, multi-center, single-arm early feasibility study enrolling a minimum of 15 subjects at up to a minimum of 3 active investigational sites in the United States. The subjects must be diagnosed with acute ischemic stroke (AIS), must be post-mechanical thrombectomy, will have had intravenous thrombolytics, and have a visible MCA, ACA or PCA occlusive clot on initial angiographic imaging. Each subject will receive the Pulse NanoMED procedure after attempted neurovascular therapy to achieve better reperfusion.
Eligibility Criteria
Inclusion Criteria: 1. The participant provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) or an acceptable patient surrogate. 2. The participant is ≥ 18 years old and less than 85 years old. 3. Patients with symptomatic large vessel occlusion (LVO) who undergo MT as part of their standard of care and have residual occlusion involving the anterior, middle or posterior cerebral arteries resulting in a eTICI score greater than 2b50 at the end of the procedure with three or less MT device passes. 4. Estimated delay to onset of rescue Pulse NanoMED MicroBead administration \<9 hours from symptom onset, defined as the point in time the patient was last known well (LKW). 5. Post-MT and has had thrombolytic therapy \<9 hours prior to the proposed start time of System therapy 6. No significant pre-stroke functional disability (modified Rankin scale 0-1) 7. Baseline NIHSS≥6 8. ASPECTS \>6 on non-contrast CT