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Clinical Trial Summary

A Phase II, randomized, blinded, placebo-controlled, parallel group study with patients experiencing a large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization. Participants will be given a 48 h infusion of either 0.5 mL/kg/h RNS60 (up to a maximum of 60 mL/h), 1 mL/kg/h RNS60 (up to a maximum of 120 mL/h), or 1 mL/kg/h (up to a maximum of 120 mL/h) placebo (normal saline) starting within 30 minutes of consent after confirmation of candidacy for endovascular thrombectomy.


Clinical Trial Description

This study is a Phase II, randomized, blinded, placebo-controlled, parallel group design. Participants experiencing a large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization will be given a 48 h infusion of either 0.5 mL/kg/h RNS60 (up to a maximum of 60 mL/h), 1 mL/kg/h RNS60 (up to a maximum of 120 mL/h), or 1 mL/kg/h (up to a maximum of 120 mL/h) placebo (normal saline) starting within 30 minutes of consent after confirmation of candidacy for endovascular thrombectomy and prior to arterial closure. Outcomes of the main trial will be evaluated throughout a 90 day observation period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04693715
Study type Interventional
Source Revalesio Corporation
Contact
Status Completed
Phase Phase 2
Start date July 7, 2021
Completion date November 8, 2023

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