Principal Investigators:

• Andrew Demchuk, MD
• Pooja Khatri, MD, Msc
• Simon Nagel, MD
• Raul Nogueira, MD

Login

Welcome

ENDOLOW is a Phase 2/3, prospective, randomized, open-label, blinded-endpoint (PROBE) adaptive two-stage design trial allowing for early stopping for efficacy or futility after the first stage or continuation with stage two including the option of recalculating the sample size. This study will be testing efficacy and safety of immediate mechanical thrombectomy (iMT) initiated within 8 hours in conjunction with medical management versus initial medical management (iMM) alone administered in patients presenting with cerebral ischemia in the setting of proximal large vessel occlusions (LVO) and low baseline NIHSS scores (NIHSS 0-5). LVO is defined as occlusion involving the internal carotid artery (ICA) and the M1 segment of the middle cerebral artery (MCA). The primary endpoint will be a categorical shift across all levels on the modified Rankin Scale (mRS) at 90-days post-randomization. The hypothesis is that iMT will lead to an improved clinical outcome at 90 days.Interim analysis will be performed after the primary endpoint is available for a total of 175 randomized patients.

Inclusion/Exclusion Criteria Version 1.4
Inclusion/Exclusion Criteria Version 1.5