POSITIVE Stroke Clinical Trial

Exclusion Criteria

• •1. Patient is less than 6-hours from symptom onset
• •2. Rapidly improving neurologic examination
• •3. Absence of large vessel occlusion on non-invasive imaging
• •4. Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory
• •5. Absence of an associated large penumbra as defined by physiologic imaging according to standard of practice at the participating institution
• •6. Any intracranial hemorrhage in the last 90 days
• •7. Known irreversible bleeding disorder
• •8. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 2.5 or institutionally equivalent prothrombin time of 2.5 times normal
• •9. Platelet count \< 100 x 103 cells/mm3 or known platelet dysfunction
• •10. Inability to tolerate, clinically documented evidence in medical history of adverse reaction to, or contraindication to medications used in treatment of the stroke
• •11. Contraindication to CT and MRI (i.e., iodine contrast allergy or other condition that prohibits imaging from either CT or MRI)
• •12. Known allergy to contrast used in angiography that cannot be medically controlled
• •13. Relative contraindication to angiography (e.g., serum creatinine \> 2.5 mg/dL)
• •14. Women who are currently pregnant or breast-feeding (Women of child-bearing potential must have a negative pregnancy test prior to the study procedure (either serum or urine)
• •15. Evidence of active infection (indicated by fever at or over 99.9 °F and/or open draining wound) at the time of randomization
• •16. Current use of cocaine or other vasoactive substance
• •17. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days
• •18. Patients who lack the necessary mental capacity to participate or are unwilling or unable to comply with the protocol's follow up appointment schedule (based on the investigator's judgment)
• •Presence of blood on imaging (subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), etc.)
• •High density lesion consistent with hemorrhage of any degree
• •Significant mass effect with midline shift
• •Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan or ASPECTS of \< 7; Sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment