REal-World Analyses of Stroke - Thrombus Occlusion REtrieval

Exclusion Criteria

• •1. Inability to obtain written informed consent.
• •2. Patient is \< 21 or \> 85 years of age.
• •3. Patient has a pre-morbid mRS ≥ 2.
• •4. More than 8 hours have passed since symptom onset.
• •5. Severe unilateral or bilateral carotid artery stenosis or dissection requiring stent treatment.
• •6. Presence of a pre-existing large territory infarction.
• •7. Absent femoral pulses or other condition preventing femoral access.
• •8. Patient has vascular anatomy/tortuosity or other vascular disease preventing access to the target occlusion or that will likely result in unstable access.
• •9. Patient is pregnant.
• •10. Known or suspected pre-existing/chronic large vessel occlusion in the symptomatic territory.
• •11. Patient has known, untreatable hypersensitivity to contrast dye, iodine or any component of the treatment device that cannot be medically controlled.
• •12. The intracranial occlusion is suspected to be chronic based on past imaging, clinical history, or clinical judgment.
• •13. Patient has a severe or life-threatening comorbidity that could confound study results, or that will render the procedure unlikely to benefit the patient.
• •14. Patient is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 3 months.
• •15. Patient is enrolled in another device or drug study in which participation could confound study results.
• •* Presence of intracerebral hemorrhage as evidenced on initial imaging
• •* Ischemic changes in the posterior circulation territories (including the vertebra-basilar and posterior cerebral arteries)
• •* Significant mass effect with midline shift
• •* Evidence of intracranial tumor
• •* Baseline ischemic core lesion \>50 cc
• •* Involvement of \> 1/3 of the middle cerebral artery territory
• •* ASPECTS \<6 (hemispheric sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment)
• •Cohort II:
• •1. Inability to obtain written informed consent within 48 hours of procedure.
• •2. Patient is enrolled in another device or drug study in which participation could confound study results.