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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Guangzhou University of Traditional Chinese Medicine

Current Primary Outcome: the total number of all-cause mortality and all-cause stroke within 12 months [ Time Frame: After 12 months follow-up ]

After drug-use 12 months,observe all-cause mortality and all-cause stroke（hemorrhage or ischemic）.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The rate of intracranial in-stent restenosis [ Time Frame: 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 [ Time Frame: 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） [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: After 12 months follow-up period ]
    modified RANKIN score.


Original Secondary Outcome: Same as current

Information By: Guangzhou University of Traditional Chinese Medicine

Dates:
Date Received: December 20, 2016
Date Started: January 2017
Date Completion: December 2019
Last Updated: December 29, 2016
Last Verified: December 2016