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

Guangzhou University of Traditional Chinese Medicine180 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

180

Conditions

Occlusion and Stenosis of Unspecified Cerebral Artery

Interventions

Herbal Medicine C-117DRUG

C117 formula including 2 herbals and 2 insects

The Placebo of Herbal Medicine C-117DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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）.

Time frame: After 12 months follow-up

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: After 12 months follow-up period

modified RANKIN score.

Time frame: After 12 months follow-up period

Central Contacts

Jianwen Guo, doctor

CONTACT

0086-13724899379 jianwen_guo@msn.com

jianwen guo, MD

CONTACT

(08620)81887233 306247680@qq.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.