A Phase III, Randomized, Multicenter, Investigational, Open Label Clinical Trial That Will Examine Whether Treatment With Endovascular Thrombectomy is Superior to Standard Medical Therapy Alone in Patients Who Suffer a Distal Medium Vessel Occlusion Ischemic Strokes.
A phase III, randomized, multi-center, investigational, open label clinical trial that will examine whether treatment with endovascular thrombectomy is superior to standard medical therapy alone in patients who suffer a Distal Medium Vessel Occlusion Ischemic Stroke within 12 hours from time last seen well
• Age ≥18 years (no upper age limit)
• Acute ischemic stroke where patient is ineligible for or has failed\* IV thrombolytic treatment and is ineligible for endovascular treatment under best guideline-based care due to absence of proximal arterial occlusion (e.g. intracranial ICA, MCA-M1 and co-dominant or dominant M2\*\* segments, and vertebrobasilar arteries).\*\*\*
• \* IV thrombolytic treatment failure is defined by persistent disabling neurological deficits beyond 60 minutes of completion of thrombolytic infusion in the presence of imaging findings consistent with DMVO.
• \*\*Dominant M2 segment is defined is a division supplying \>50% of the MCA territory vs co-dominant supplying 50% of the MCA territory vs non-dominant supplying \<50% of the MCA territory.
• \*\*\*No procedures or tests required by the protocol will delay fastest possible delivery of thrombolytic therapy to potentially eligible subjects.
• Evidence of a primary (e.g. not secondary to EVT of proximal vessel occlusion) distal medium vascular occlusion defined as occlusion of the non-dominant M2 segment or M3 segment of the MCA, the ACA (A1, A2, or A3 segments), or the PCA (P1, P2 or P3 segments) resulting in significant clinical deficits and expected to be treatable by endovascular thrombectomy. Regardless of vessel anatomic location, all vessel diameters should be within 1.5mm -2.5mm. (refer to the device labeling for recommended vessel diameters for each device model.)\*
• No significant pre-stroke functional disability (mRS ≤2)
• Evidence of a disabling stroke defined as follows:
‣ Baseline National Institutes of Health Stroke Scale (NIHSS) score \>5 at the time of randomization.
⁃ NIHSS 3-5 with disabling deficit including significant aphasia, neglect, hemianopsia, or hemiparesis/ loss of hand or leg function as established by the treating team in context of the patient's life.
• The presence of a Target Mismatch defined as:
‣ Ischemic Core \< 50cc (defined on NCCT/CTP\* or DWI-MRI)
‣ \*Visual or automatedly detected hypodensity on NCCT should be used to exclude or include patients if the investigator believes that their assessment is more reliable than the CTP volume in any particular case.
⁃ Mismatch Volume (TMax \>6sec lesion - Core volume lesion) \>10cc
⁃ Mismatch Ratio \>1.4
• Patient treatable within 12 hours of symptom onset. Symptoms onset is defined as the point in time the patient was last seen well (at baseline). Treatment start is defined as the time of arterial puncture.
• Informed consent obtained from patient or acceptable patient surrogate