IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT)

Exclusion Criteria

• •1. Intracranial arterial stenosis not caused by atherosclerotic lesions, such as arterial dissection, moya-moya disease, vasculitic disease, viral vascular lesions (e.g., herpes zoster, varicella), neurosyphilis, other intracranial infections, radiation-induced vasculopathy, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, benign central nervous system vascular diseases, postpartum angiopathy, suspected vasospastic process, suspected recanalized embolus, etc.
• •2. Any conditions that precludes proper angiographic assessment.
• •3. Preoperative MRI indicating only lacunar infarction in the target lesion territory.
• •4. History of subarachnoid hemorrhage, subdural or epidural hematoma within 30 days prior to enrollment, or untreated chronic subdural hematoma thickness≥5mm, or history of primary intracerebral hemorrhage.
• •5. At risk of hemorrhagic transformation during the procedure (CT or MRI showing infarct area diameter \>5 cm); hemorrhagic transformation of an ischemic stroke within the past 15 days (detected by CT).
• •6. Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion
• •7. Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which lesion is symptomatic (for example, if patient has pon, midbrain, temporal and occipital symptoms).
• •8. Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date.
• •9. 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
• •10. Severe vascular tortuosity, severe calcification, or other factors that would preclude the safe introduction of a guiding catheter, guiding sheath or stent placement.
• •11. Presence of intraluminal thrombus proximal to or at the target lesion.
• •12. Any aneurysm proximal to or distal to intracranial stenotic artery.
• •13. Intracranial tumors or any intracranial vascular malformations.
• •14. Potential cardiac sources of emboli such as atrial fibrillation, left ventricular thrombus, heart valve replacement, atrial septal defect, ventricular septal defect, atrial myxoma, etc.
• •15. Myocardial infarction within previous 30 days.
• •16. Suspected severe allergy or contraindication to vascular interventional-related drugs or devices, such as aspirin, clopidogrel, general anesthesia agents, heparin, contrast agents, nitinol alloy, etc.
• •17. Active bleeding diathesis or coagulopathy, active gastrointestinal ulcer, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets count \<100,000, hematocrit \<30, INR \>1.5, dysfunctions of the blood coagulation system.
• •18. uncontrolled severe hypertension (systolic BP\>180mm Hg or diastolic BP\>110mm Hg)
• •19. Severe comorbidities or unstable conditions, such as severe heart failure, respiratory failure, or renal failure (serum creatinine\>264μmol/L, unless on dialysis), severe liver dysfunction (ALT or ALT \>3 times normal), malignant tumors.
• •20. Major surgery performed within 30 days prior to enrollment or planned inpatient surgery within 90 days after enrollment.
• •21. Pregnancy or intent to become pregnant during the trial period.
• •22. Currently participating in another clinical trial.
• •23. Life expectancy less than 3 years
• •24. Patients unable to complete follow-up due to cognitive impairment, emotional disorders, or mental illness.