Symptomatic Intracranial Atherosclerotic Stenosis
Conditions
Interventions
control group:Conventional Western medical treatment (dual antiplatelet aggregation) + Yiqi Tongluo formula placebo orally
Sponsors
Dongfang Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Age =18 years; 2) sICAS patients with recurrent ischemic stroke or TIA (within the last 90 d) despite standardized medical treatment with antiplatelet aggregating drugs statins and control of risk factors; 3) DSA confirmation that the responsible vessel is an intracranial large artery (including the intracranial segment of the internal carotid artery (segments C5-C7) the horizontal segment of the middle cerebral artery (M1) the intradural segment of the vertebral artery ( (including intracranial large carotid arteries (intracranial segment of intracranial carotid artery (C5 to C7) (M1 segment) intradural segment of vertebral artery (V4 segment) basilar artery) and stenosis of =70% of the diseased vessels; 4) Poor cerebral collateral circulation compensation with collateral circulation grading of 0-2 using the Collateral Circulation Assessment System (CCAA) of the American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology and cerebral CT perfusion imaging suggestive of hypoperfusion in the area of the responsible vascular vessel; 5) High-resolution magnetic resonance angiographic images of the vessel walls to identify stenotic vessels according to the wall thickness and enhancement 5) Atherosclerosis was identified as the cause of stenosis on high-resolution magnetic resonance angiography based on vessel wall thickening and enhancement and at least 1 atherosclerosis risk factor (e.g. hypertension diabetes mellitus hyperlipidemia hyperhomocysteinemia or cigarette smoking). 6) Those who were diagnosed to have qi deficiency or blood stasis by the Criteria for the Identification and Diagnosis of Stroke Diseases. 7) A pre-morbidity mRS score of 0-2. 8) Those who were able to voluntarily participate in this study and signed an informed consent.
Exclusion criteria
Exclusion criteria: 1) Acute phase of IS (onset = 24 h); 2) Expected survival 70% in arteries other than the target vessel and its main supplying arteries; 9) stenosis in the main supplying arteries of the target vessel. 9) Stenosis >50% in the main blood supply artery of the target vessel e.g. >50% stenosis of the ipsilateral internal carotid artery in the middle cerebral artery >50% stenosis of the dominant vertebral artery in the basilar artery and >70% stenosis of the extracranial arteries of the non-responsible vessel. 10) Intracranial hemorrhage in the last 3 months including parenchymal ventricular subarachnoid epidural and epidural hemorrhages and other intracranial hemorrhages. 10) Intracranial hemorrhage within the past 3 months including cerebral parenchymal hemorrhage ventricular hemorrhage subarachnoid hemorrhage epidural hemorrhage and subdural hemorrhage etc.; 11) Previous angioplasty (including balloon dilatation stenting or endothelial debridement) of the target blood vessel or the main arteries of the blood supply or planned to stenting; 12) Those who can not stabilize the establishment of vascular access through tortuous vascular paths; 13) Those who are combined with severe damage to the heart liver kidneys etc. and those who are pregnant; 14) Those who are accompanied by psychiatric diseases mental disabilities 15) Those who are participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responsible vascular restenosis rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| HS-CRP\HCY\ HDL\LDL\Apo-B\Ox-LDL\TG\FABP4\VEGF\TIMP-1\MMP-9;mRS\NIHSS\BI;Incidence of restenosis within 6 months of enrollment;Chinese Medicine Evidence Score, Stroke Diagnosis and Efficacy Score, Chinese Medicine Evidence Scoring;Any stroke (hemorrhagic/ischemic stroke) outside of the target vessel's blood supply area within 3 months and 6 months of enrollment;Improvement of local hemodynamics and whole brain perfusion in the responsible vessel at 3 and 6 months of enrollment;Incidence of any stroke (hemorrhagic/ischemic stroke) or death in the target-vessel-supplying area within 3 and 6 months of enrollment; | — |
Countries
CHINA
Contacts
Public ContactGesheng Wang
Dongfang Hospital Beijing University of Chinese Medicine
Outcome results
None listed