Endovascular Therapy for Low NIHSS Ischemic Strokes (ENDOLOW)
Cerebral Ischemia
About this trial
This is an interventional treatment trial for Cerebral Ischemia focused on measuring Immediate Mechanical Thrombectomy, Initial medical management, Large vessel occlusion, Efficacy, Safety
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- Acute ischemic stroke based on clinical diagnosis (NIHSS 0-5) and presence of an objective neurological deficit
- Patients eligible for intravenous rt-PA should receive this therapy as soon as possible and no later than 4.5 hours from symptom onset
Proximal Intracranial Artery Occlusion on Imaging by NCCT/CTA or MRI/MRA showing complete occlusion of the intracranial ICA, M1, or an "M1-like" M2 vessel with or without tandem cervical lesion. Notably, "M1-like" M2 vessel occlusions are defined functionally for the trial as following:
On CTA: Occlusion of both branches after MCA division (both M2s occluded) or occlusion of the larger diameter M2 branch . In case of trifurcations, either the two largest M2 branches are occluded or the occluded M2 has a larger diameter than the combined diameter of the two other M2s . Notably, the M2 origins are defined by the first branching point in the MCA other than the anterior temporal artery rather than by anatomic landmarks (e.g., horizontal versus insular location).
or
- If mCTA or CTP performed (optional): a M2 occlusion which supplies a large proportion of the MCA territory by evidence of either:
i. The bulk (>2/3) of the MCA territory has evidence of delayed washout on multiphase CT or ii. Perfusion imaging shows a hypoperfusion lesion volume involving a significant proportion of the MCA territory defined as Tmax >4 sec lesion of ≥100 mL
Baseline Infarct Core of either:
- Baseline ASPECTS ≥6 on non-contrast CT (NCCT), or
- Baseline Infarct Core Volume of < 70cc on either CTP (Volume of rCBF <30%) or DWI if quantitative software tools are available (neither test is mandatory for study)
Exclusion Criteria:
- NIHSS ≥6
- Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH)
- Any imaging findings suggestive of futile recanalization in the judgment of the local investigator
- High degree of suspicion of intracranial arterial disease (ICAD), such as evidence of multifocal ICAD
- Premorbid disability (mRS ≥3)
- Inability to randomize within 8 hours of last known well
- Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
- Baseline blood glucose of <50 mg/dL (2.78 mmol) or >400 mg/dL (22.20 mmol)
- Known coagulation disorders as defined as platelet count <100,000/uL
- Known renal failure as defined as serum creatinine levels > 3.0 mg/dL
- Presumed septic embolus or suspicion of bacterial endocarditis
- Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
- Participation in another investigational treatment study in the previous 30 days
- Intubation and mechanical ventilation prior to study enrollment is medically indicated
- History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Site investigator does not have equipoise towards the ideal treatment concept (thrombectomy vs. best medical management)
- Known pregnancy
- Prisoner or incarceration
- Known acute symptomatic COVID-19 infection
Sites / Locations
- Providence Little Company of Mary Medical CenterRecruiting
- Baptist Health Jacksonville FLRecruiting
- University of Miami Miller School of MedicineRecruiting
- Grady Health System (non-CRN)Recruiting
- Rush University Medical Center: University NeurosurgeryRecruiting
- Advocate Aurora HealthRecruiting
- Indiana UniversityRecruiting
- University of IowaRecruiting
- Baptist Health Lexington
- University of Massachusetts Medical CenterRecruiting
- Michigan Medicine Comprehensive Stroke Center
- Henry Ford Health SystemRecruiting
- McLaren Health Care Corporation
- Washington University School of MedicineRecruiting
- JFK Neurosciences Center
- Thomas Jefferson UniversityRecruiting
- Albany Medical CenterRecruiting
- University at Buffalo Neurosurgery/ Kaleida HealthRecruiting
- Icahn School of Medicine at Mount SinaiRecruiting
- University of CincinnatiRecruiting
- Cleveland ClinicRecruiting
- Ohio State Wexner Medical CenterRecruiting
- Riverside Medical Center, OhioHealth Research InstituteRecruiting
- Oregon Health & Science University
- Prisma Health-UpstateRecruiting
- Semmes Murphey Foundation
- Texas Tech University Health Sciences Center at El PasoRecruiting
- VHS-Harlingen Hospital Company dba Valley Baptist Medical Center-Harlingen
- University of Calgary and Foothills Medical CentreRecruiting
- University of Alberta Hospital
- University of Manitoba
- London Health Sciences CentreRecruiting
- Trillium Health Partners
- The Ottawa Hospital Civic Campus
- Sunnybrook Health Sciences Centre
- Montreal Neurological Institute and Hospital
- University of Saskatchewan
- Universitätsklinikum Freiburg, Klinik für Neurologie
- Universitäts Klinikum Heidelberg
- Ludwig Maximilian University, Department of Neurology
- Institute of Neuroradiology, University Hospital Frankfurt
- Universitätsmedizin Göttingen
- Klinikum Osnabrueck, Department of Neurology
- Universitätsklinikum Essen
- University Hospital Carl Gustav Carus Dresden Dresden, Department of Neurology
- University Hospital Schleswig-Holstein, Campus Kiel
- Gesundheit Nord Klinikum Bremen-Mitte
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Immediate mechanical thrombectomy(iMT)
Initial medical management (iMM)
Treatment initiation within 8 hours of symptom onset. Arterial puncture and revascularization will be performed using EmboTrap II Retriever. The procedure will be completed within two hours of arterial access.
Standard medical therapy based on current AHA (American Heart Association) guidelines. Rescue mechanical thrombectomy (rMT) is allowed for patients initially assigned to iMM if they suffer major neurological worsening that clearly requires an intra-arterial intervention in the judgment of the treating team.