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Angioplasty and stenting for patients with symptomatic intracranial atherosclerosis: study protocol of a randomised

Xiao-Ping Cui1, Min Lin1, Jun-Shan Mu1

  • 1Department of Neurology, Fuzhou General Hospital of Nanjing Command, People's Liberation Army and Clinical Medical College of Fujian Medical University, Fuzhou, China.

BMJ Open
|November 18, 2016
PubMed

Insights

This study investigates if percutaneous transluminal angioplasty and stenting (PTAS) improves outcomes for symptomatic intracranial atherosclerosis (ICAS). The randomized trial compares PTAS plus medical treatment versus medical treatment alone to assess stroke and death incidence.

Area of Science:

  • Neurology
  • Interventional Cardiology
  • Clinical Trials

Background:

  • Symptomatic intracranial atherosclerosis (ICAS) poses a significant risk of stroke.
  • The efficacy of percutaneous transluminal angioplasty and stenting (PTAS) as an adjunct to medical treatment for ICAS remains debated.
  • There is a need to evaluate improved PTAS procedures for managing ICAS.

Purpose of the Study:

  • To determine the effectiveness and safety of an improved PTAS procedure combined with medical treatment (MT) for patients with symptomatic ICAS.
  • To compare the incidence of stroke or death in patients receiving MT plus PTAS versus MT alone.
  • To assess secondary outcomes including ischemic stroke, restenosis, and quality of life.

Main Methods:

  • A randomized controlled trial conducted in three Chinese hospitals.
  • Eligible patients with ICAS were randomized to receive MT plus PTAS or MT alone.
  • Primary endpoint: incidence of stroke or death at 30 days. Secondary endpoints: ischemic stroke, in-stent restenosis, modified Rankin Scale, and CSQoL.

Main Results:

  • Data on the main results are not yet available as this describes a study protocol.
  • The study is registered under NCT02689037.
  • Follow-up is planned at 30 days, 3 months, and 12 months post-randomization.

Conclusions:

  • The study aims to provide evidence to guide clinical decision-making for ICAS management.
  • Findings are expected to inform improvements in current PTAS procedures.
  • Dissemination of results will occur through peer-reviewed publications and conference presentations.
Abstract

Keywords:
Angioplasty and Stentingstudy protocolsymptomatic intracranial atherosclerosis

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