Clinical trial NCT03008798: Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117
Official title: Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117--PRISIT Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Occlusion and Stenosis of Unspecified Cerebral Artery
Keywords: Intracranial Artery
in-stent restenosis
Herbal Medicine
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Liaocheng People's Hospital
name: Liaoning Cancer Hospital & Institute
name: Zhongshan People's Hospital, Guangdong, China
First posted: 2017-01-02
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: the total number of all-cause mortality and all-cause stroke within 12 months
timeFrame: After 12 months follow-up
Secondary outcomes:
measure: The rate of intracranial in-stent restenosis
timeFrame: After 12 months follow-up period,record the rate of intracranial in-stent restenosis
measure: The complications of intracranial in-stent restenosis
timeFrame: After 12 months follow-up period,record the complications of intracranial in-stent restenosis
measure: NIH Stroke Scale （NIHSS）
timeFrame: After 12 months follow-up period
measure: Bathel index
timeFrame: After 12 months follow-up period
measure: modified RANKIN score.
timeFrame: After 12 months follow-up period
Other outcomes:
Locations:
Study officials:
affiliation: Guangdong Province Hospital of Tradtional Chinese Medicine
name: Yingguang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liaocheng People's Hospital
name: Zhangyong Xia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liaoning Cancer Hospital & Institute
name: Jian Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhangshan People's Hospital
name: Wentong Ling, MD
role: PRINCIPAL_INVESTIGATOR
References: