ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients

Exclusion Criteria

• •NIHSS ≥30 or comatose
• •Known to be pregnant
• •Serum glucose level \<50 mg/dL
• •Excessive cervical arterial tortuousity that prevents placement of the retrieval devices
• •Known hemorrhagic diathesis
• •Patients exhibiting signs suggestive of or angiographic evidence of bilateral stroke
• •Coagulation factor deficiency (or oral anticoagulation therapy with INR\>3.0)
• •In receipt of heparin within 48 hours with a PTT \> 2x the lab normal
• •Baseline platelets \<30,000 mm3
• •Known serious sensitivity to intra-arterial radiographic contrast agents
• •Severe sustained hypertension (systolic blood pressure \> 185 mmHg or diastolic \>110 mmHg)
• •Baseline CT or MRI revealed significant mass effect with midline shift or greater than 1/3 of the MCA region with hypodensity (sulcal effacement and/or loss of gray-white differentiation is allowed)
• •Neurologic signs that are rapidly improving at the time of treatment as measured by a decrease in NIHSS score of 4 or more points as determined prior to or at the time of treatment as compared to the initial screen
• •CT or MRI evidence of hemorrhage on presentation
• •CT or MRI evidence of mass effect or intracranial tumor (except small meningioma)
• •Life expectancy \< 3 months
• •Angiographic evidence of carotid dissection, or high grade stenosis (\> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or vasculitis
• •At the discretion of the investigator, patients with co-morbidities associated with a life expectancy of less than 3 months or co-morbidities that could influence the study results or make clinical follow-up difficult will be excluded.