Occlusion and Stenosis of Unspecified Cerebral Artery
Conditions
Keywords
Intracranial Artery, in-stent restenosis, Herbal Medicine
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.
Interventions
C117 formula including 2 herbals and 2 insects
Sponsors
Liaocheng People's Hospital
Liaoning Cancer Hospital & Institute
Zhongshan People's Hospital, Guangdong, China
Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Older than 18 years of age 2. 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%. 3. The score of mRS≤3 4. To rule out intracranial hemorrhage by CT orMRI 5. Adhere to the medication
Exclusion criteria
： 1. Together with intracranial tumors or AVM 2. The lesion area where implant stent previons 3. Fetch intracranial artery thrombus by emergency surgical operation 4. Vascular serious circuity 5. Myocardial infarction need to antithrombotic 6. MoyaMoya disease or cerebral vasculitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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. |
Contacts
Primary ContactJianwen Guo, doctor
Backup Contactjianwen guo, MD
Outcome results
None listed