Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117
- Conditions
- Occlusion and Stenosis of Unspecified Cerebral Artery
- Interventions
- Drug: Herbal Medicine C-117Drug: The Placebo of Herbal Medicine C-117
- Registration Number
- NCT03008798
- Brief Summary
Prevention for the Restenosis of Intracranial artery Stent Implantation Treated with herbal medicine C117--PRISIT Trial
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Herbal Medicine C-117 Herbal Medicine C-117 Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year The Placebo of Herbal Medicine C-117 The Placebo of Herbal Medicine C-117 The Placebo of Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year
- Primary Outcome Measures
Name Time Method the total number of all-cause mortality and all-cause stroke within 12 months After 12 months follow-up After drug-use 12 months,observe all-cause mortality and all-cause stroke（hemorrhage or ischemic）.
- Secondary Outcome Measures
Name Time Method The rate of intracranial in-stent restenosis After 12 months follow-up period,record 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.
NIH Stroke Scale （NIHSS） After 12 months follow-up period At the time of 6 and 12 months,we will have a follow-up to assess the patient's NIHSS
The complications of intracranial in-stent restenosis After 12 months follow-up period,record 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.
Bathel index After 12 months follow-up period At the time of 6 and 12 months,we will have a follow-up to assess the patient's NIHSS, Bathel index
modified RANKIN score. After 12 months follow-up period modified RANKIN score.