Surgical Indirect Revascularization For Symptomatic Intracranial Arterial Stenosis

Exclusion Criteria

• •1. Tandem extracranial or intracranial stenosis (70-99%) or occlusion that is proximal or distal to the target intracranial lesion
• •2. Bilateral intracranial vertebral artery stenosis of 70% to 99% and uncertainty about which artery is symptomatic (e.g., if patient has pontine, midbrain, or temporal occipital symptoms)
• •3. Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days before the expected enrollment date
• •4. Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform staged angioplasty followed by stenting of target lesion
• •5. Plan to perform concomitant angioplasty or stenting of an extracranial vessel tandem to an intracranial stenosis
• •6. Presence of intraluminal thrombus proximal to or at the target lesion
• •7. Any aneurysm proximal to or distal to the stenotic intracranial artery
• •8. Intracranial tumor (including meningioma) or any intracranial vascular malformation
• •9. Computed tomographic or angiographic evidence of severe calcification at target lesion
• •10. Thrombolytic therapy within 24 hours before enrollment
• •11. Progressive neurologic signs within 24 hours before enrollment
• •12. Brain infarct within previous 30 days of enrollment that is of sufficient size (\> 5 cm) to be at risk of hemorrhagic conversion during or after surgery
• •13. Any hemorrhagic infarct within 14 days before enrollment
• •14. Any hemorrhagic infarct within 15 to 30 days that is associated with mass effect
• •15. Any history of a primary intracerebral (parenchymal) hemorrhage
• •16. Any other intracranial hemorrhage (subarachnoid, subdural, or epidural) within 30 days
• •17. Any untreated chronic subdural hematoma \>5 mm in thickness
• •18. Intracranial arterial stenosis related to arterial dissection, Moya-Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process, and suspected recanalized embolus
• •19. Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction \<30%
• •20. Known allergy or contraindication to aspirin and local or general anesthesia
• •21. History of life-threatening allergy to contrast dye. If not life-threatening and can be effectively pretreated, patient can be enrolled at physician's discretion
• •22. Known absolute contraindication to obtaining MRI studies, such as magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neuro-stimulators, and cochlear implants), MRI incompatible orthopedic implants, and free metallic fragments in the brain or eye.
• •23. Active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets \<100,000, hematocrit \<30, INR \>1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, uncontrolled severe hypertension (systolic BP\>180 mm Hg or diastolic BP\>115 mm Hg), severe liver impairment (AST or ALT \> 3 times normal, cirrhosis), creatinine \> 3.0 (unless on dialysis)
• •24. Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment
• •25. Indication for warfarin or heparin beyond enrollment (NOTE: Exceptions allowed for use of subcutaneous heparin for deep venous thrombosis prophylaxis while hospitalized)
• •26. Severe neurologic deficit that renders the patient incapable of living independently
• •27. Dementia or psychiatric problem that prevents the patient from following an outpatient program reliably
• •28. Comorbid conditions that may limit survival to \< 3 years
• •29. Females who are pregnant or of childbearing potential and unwilling to use contraception for the duration of this study
• •30. Enrollment in another study that would conflict with the current study
• •1. Use of clopidogrel or extended release dipyridamole within 7 days of the date of surgery. This exclusion is based on the elevated risk of hemorrhagic complications for intracranial surgery using those agents according to the current AHA/ACC Guidelines (Fleisher et al., 2007).
• •2. Evidence of active, un-treated focal or systemic infections (i.e. pneumonia, urinary tract infection, skin abscess) or history of recurrent infections despite treatment in the last 6 months.
• •3. Coagulation disorders characterized by a PTT ≥ 34, or a PT ≥ 12, or an INR ≥ 1.3, or a platelet count of \<80,000.
• •4. Non-controlled hyperglycemia (any pre-prandial glucose level ≥ 180 mg/dL in any single test within 30 days before enrollment) or a hemoglobin A1c (HbA1c) ≥7%.
• •5. A low-density lipoprotein cholesterol (LDL-c) ≥ 130 mg/dL.
• •6. A non-high-density lipoprotein cholesterol (non-HDL-c) ≥ 100 mg/dL.
• •7. Smoking history in the last 6 months.
• •8. BMI ≥ 30 kg/m2