Clinical Trial: Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis

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

Official Title: Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis: Study Protocol of a Randomized Controlled Trial

Brief Summary:

Background: Effectiveness of Percutaneous transluminal angioplasty and stenting (PTAS) on prevention of events of stroke and death in patients with symptomatic intracranial atherosclerosis (ICAS) is controversial.

Aim: to determine whether PTAS plus medical treatment (MT) are superior to MT alone in preventing events of stroke and death in patients with symptomatic ICAS.

Methods: The investigators will carry out a randomized controlled trial in 3 hospitals in China. A total of 198 patients with ICAS will be randomized into 2 groups: PTAS+MT and MT group. All patients will receive aspirin (100 mg daily) and clopidogrel (75 mg daily) immediately after randomization, and patients in PTAS+MT group will receive surgery within 5 days after randomization. The patients will be followed up for 1 year after randomization and assessed for events of stroke and death at 30 days and 1 year after randomization, the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory at 30 days and 1 year after randomization, incidence of in-stent restenosis at 1 year after randomization,etc.


Detailed Summary:
Sponsor: The 476th Hospital of People's Liberation Army

Current Primary Outcome: Proportion of patients with events of stroke or death [ Time Frame: at 30 days after randomization ]

Original Primary Outcome: Proportion of patients with events of stroke or death [ Time Frame: within 30 days after initiation of treatment ]

Current Secondary Outcome:

  • the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory [ Time Frame: 30 days and 1 year after randomization ]
  • neurological functional outcome by the Chinese version of National Institutes of Health Stroke Scale (C-NIHSS) [ Time Frame: 30 days and 1 year after randomization ]
  • Proportion of patients with adverse events [ Time Frame: 30 days and 1 year after randomization ]


Original Secondary Outcome:

  • the rate of successful recanalisation (stenosis<50%) [ Time Frame: instantly after the procedure ]
  • the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory [ Time Frame: 30 days and 1 year postoperatively ]
  • neurological functional outcome by the Chinese version of National Institutes of Health Stroke Scale (C-NIHSS) [ Time Frame: 30 days and 1 year postoperatively ]
  • Proportion of patients with adverse events [ Time Frame: 30 days and 1 year postoperatively ]


Information By: The 476th Hospital of People's Liberation Army

Dates:
Date Received: February 17, 2016
Date Started: April 2016
Date Completion: December 2019
Last Updated: April 4, 2016
Last Verified: April 2016