Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117

Study Overview
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Brief Summary
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Prevention for the Restenosis of Intracranial artery Stent Implantation Treated with herbal medicine C117--PRISIT Trial

Detailed Description
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Intracranial artery stenosis (ICAS) is a common cause of ischemic stroke worldwide. At present, percutaneous transluminal angioplasty and stenting serve as a possible treatment option for ICAS patients, however, intracranial in-stent restenosis(ISR) limited its use in clinical practice, which led to recurrent stroke even death, meanwhile, From the point of chinese medicine, in-stent restenosis(ISR) regard as the unhealthy environmental influences with shapes, therefore, we have design two control group on the basis of conventional secondary prevention, one use herbal medicine for blood-acting and stasis-dissolving, and another use the similar looking placebos, after 12 months of treatment, we will evaluate the rate of all-cause stroke and all-cause mortality, moreover, we also record the Vascular restenosis rate which may cause recurrent ischemic stroke, the aim of this study was to evaluate the safety and efficacy of herbal medicine C-117.

Official Title
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Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117--PRISIT Trial

Conditions
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Occlusion and Stenosis of Unspecified Cerebral Artery

Intervention / Treatment
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* Drug: Herbal Medicine C-117
* Drug: The Placebo of Herbal Medicine C-117


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 years of age 70-90% stenosis of intracranial responsible angiopathic area under the DSA angiography (as judged through the WASID method);after operation vascular stenosis less than 50%. The score of mRS≤3 To rule out intracranial hemorrhage by CT orMRI Adhere to the medication Exclusion Criteria： Together with intracranial tumors or AVM The lesion area where implant stent previons Fetch intracranial artery thrombus by emergency surgical operation Vascular serious circuity Myocardial infarction need to antithrombotic MoyaMoya disease or cerebral vasculitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Herbal Medicine C-117<br>Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year | Drug: Herbal Medicine C-117<br>* C117 formula including 2 herbals and 2 insects<br>|
| Placebo Comparator: The Placebo of Herbal Medicine C-117<br>The Placebo of Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year | Drug: The Placebo of Herbal Medicine C-117<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the total number of all-cause mortality and all-cause stroke within 12 months | After drug-use 12 months,observe all-cause mortality and all-cause stroke（hemorrhage or ischemic）. | After 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of intracranial in-stent restenosis | After drug-use 12 months,observe the rate of intracranial in-stent restenosis where stent implantation.throgh the test of TCD, digital subtraction angiography. | After 12 months follow-up period,record the rate of intracranial in-stent restenosis | 
| The complications of intracranial in-stent restenosis | After drug-use 12 months,observe the complications of intracranial in-stent restenosis,including TIA and stroke,even death. | After 12 months follow-up period,record the complications of intracranial in-stent restenosis | 
| NIH Stroke Scale （NIHSS） | At the time of 6 and 12 months,we will have a follow-up to assess the patient's NIHSS | After 12 months follow-up period | 
| Bathel index | At the time of 6 and 12 months,we will have a follow-up to assess the patient's NIHSS, Bathel index | After 12 months follow-up period | 
| modified RANKIN score. | modified RANKIN score. | After 12 months follow-up period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial Artery, in-stent restenosis, Herbal Medicine