Trial | NCT03008798  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    c-117 ...

  • Study Participants

    180
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 Started
Jan 31
2017
Primary Completion
Dec 31
2019
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Jan 02
2017
Estimate

Drug Herbal Medicine C-117

C117 formula including 2 herbals and 2 insects

Drug The Placebo of Herbal Medicine C-117

Herbal Medicine C-117 Experimental

Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year

The Placebo of Herbal Medicine C-117 Placebo Comparator

The Placebo of Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year

Criteria 

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
No Results Posted