Intracranial atherosclerotic artery stenosis
Conditions
Interventions
PTAS:balloon and stenting angioplasty
Sponsors
Department of Neurosurgery, Changhai Hospital,Second Military Medical University
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. TIA or nonsevere stroke within 30 days of enrollment attributed to 70% to 99% stenosis of a major intracranial artery (carotid artery, MCA stem [M1], vertebral artery, or basilar artery); 2. Modified Rankin scale score of =140/90 mm Hg or on antihypertensive therapy); dyslipidemia (LDL >=130 mg/dL or HDL =150 mg/dL or on lipid lowering therapy); smoking; non–insulin-dependent diabetes or insulin-dependent diabetes of <15 years duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, and peripheral vascular surgery in parent or sibling who was <55 years of age for men or <65 for women at the time of the event; (3) History of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease; (4) Any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by noninvasive vascular imaging or catheter angiography and is considered atherosclerotic; (5) Aortic arch atheroma documented by noninvasive vascular imaging or catheter angiography; (6) Any aortic aneurysm documented by noninvasive vascular imaging or catheter angiography that is considered atherosclerotic; 6. Patient is willing and able to return for all follow-up visits required by the protocol and available by phone; 7. Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent.
Exclusion criteria
Exclusion criteria: 1. The ischemic symptom is caused by perforators stroke, there is no evidence of hypoperfusion; 2. Stenosis (>50%) or occlusion on the contralateral side; 3. Stenosis (>=50%) or occlusion proximal to or distal to the target lesion; 4. More than 2 stenosis (=30%) proximal to or distal to the target lesion; 5. Tandem extracranial or intracranial stenosis (70-99%) or occlusion that is proximal or distal to the target intracranial lesion (NOTE: An exception is allowed if the occlusion involves a single vertebral artery proximal to a symptomatic basilar artery stenosis and the contralateral vertebral artery is supplying the basilar artery); 6. 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); 7. Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days before the expected enrollment date; 8. 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; 9. Plan to perform concomitant angioplasty or stenting of an extracranial vessel tandem to an intracranial stenosis; 10. Presence of intraluminal thrombus proximal to or at the target lesion; 11. Any aneurysm proximal to or distal to stenotic intracranial artery; 12. Intracranial tumor (except meningioma) or any intracranial vascular malformation; 13. Computed tomographic or angiographic evidence of severe calcification at target lesion; 14. Thrombolytic therapy within 24 hours before enrollment; 15. Progressive neurologic signs within 24 hours before enrollment; 16. 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 stenting; 17. Any hemorrhagic infarct within 14 days before enrollment; 18. Any hemorrhagic infarct within 15 to 30 days that is associated with mass effect; 19. Any history of a primary intracerebral (parenchymal) hemorrhage; 20. Any other intracranial hemorrhage (subarachnoid, subdural, or epidural) within 30 days; 21. Any untreated chronic subdural hematoma >5 mm in thickness; 22. 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; 23. 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%; 24. Known allergy or contraindication to aspirin, clopidogrel, heparin, nitinol, and local or general anesthesia; 25. History of life-threatening allergy to contrast dye. If not life-threatening and can be effectively pretreated, patient can be enrolled at physicians discretion; 26. Active peptic ulcer disease, major systemic hemorrhage wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ischemic event; | — |
Contacts
Public ContactBo Hong
Outcome results
None listed