Endovascular Therapy for Low NIHSS Ischemic Strokes (ENDOLOW)

STUDY OVERVIEW

This study conducted by Emory University School of Medicine aims to investigate whether patients with cerebral ischemia due to proximal large vessel occlusions (LVO) and low baseline NIHSS scores (0-5) would benefit from immediate mechanical thrombectomy (iMT) compared to initial medical management (iMM) in terms of 90-day clinical outcomes. Currently, these patients often do not undergo immediate vessel imaging despite the potential for clinical decline or underappreciated impairments related to their mild strokes, and this study seeks to address this gap in understanding.

STUDY GOALS

The goal of this study is to assess whether patients presenting with cerebral ischemia due to proximal large vessel occlusions (LVO) and low baseline NIHSS scores (0-5) experience better 90-day clinical outcomes with immediate mechanical thrombectomy (iMT) compared to initial medical management (iMM).

LOCATION

El Paso, Texas: Texas Tech Health Sciences Center at El Paso

INCLUSION CRITERIA

  • Age 18 or older

  • Clinical diagnosis of acute ischemic stroke with NIHSS score 0-5 and objective neurological deficit

  • Eligible for intravenous rt-PA treatment within 4.5 hours of symptom onset

  • Proximal intracranial artery occlusion confirmed by imaging, including complete occlusion of intracranial ICA, M1, or "M1-like" M2 vessel occlusion

exclusion criteria

  • NIHSS score ≥6

  • Evidence of intracranial hemorrhage or signs of futile recanalization on baseline imaging

  • High suspicion of intracranial arterial disease

  • Premorbid disability (mRS ≥3)

  • Inability to randomize within 8 hours of last known well

  • Baseline blood glucose <50 mg/dL or >400 mg/dL

  • Known coagulation disorders or renal failure

  • Suspected bacterial endocarditis or septic embolus

  • Conditions hindering endovascular procedure or posing significant risk to the subject

  • Participation in another investigational treatment study in the past 30 days

  • Intubation and mechanical ventilation before study enrollment

  • History of substance use or dependence affecting study adherence

  • Investigator's lack of equipoise towards treatment options

  • Known pregnancy or incarceration

  • Acute symptomatic COVID-19 infection

For more information, visit ClinicalTrials.gov.