Efficacy and Safety of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis "ESSCAS"

Completed

Phase N/A Results N/A

Trial Description

The purpose of this study is to evaluate the efficacy and safety of stent implantation in patients with symptomatic extra- and intracranial artery stenosis and to determine its role in secondary prevention of ischemic stroke.

Conditions

Interventions

  • Stent implantation (Wingspan, Coroflex, and TiTAN2) Device
    Intervention Desc: Stent Implantation: Wingspan intracranial stent with Gateway PTA balloon Catheter; Coroflex&reg - balloon expandable stent system and Coroflex Blue - Coronary Stent System; TiTAN2 Bio-active coating stent Standard Medical Management:including antiplatelet agents(Aspirin 75~150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary,interactive education program (Online medical education program, health behavior guide) . Arms: 1
    ARM 1: Kind: Experimental
    Label: 1
  • Standard medical treatment Drug
    Intervention Desc: Standard Medical Management:including antiplatelet agents(Aspirin 75~150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary,interactive education program (Online medical education program, health behavior guide)
    ARM 1: Kind: Experimental
    Label: 2

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Ischemic stroke in the supply area of stent implantation artery 30 days and 1 year after the procedure Yes
Secondary Hemorrhagic stroke 30 days and 1 year after the procedure Yes
Secondary Ischemic stroke in the supply area of non-stent implantation artery 30 days and 1 year after the procedure Yes
Secondary Acute coronary syndrome 30 days and 1 year after the procedure Yes
Secondary All-cause death 30 days and 1 year after the procedure Yes
Secondary Transient ischemic attack 30 days and 1 year after the procedure Yes
Secondary Degree of re-stenosis of the stent implantation artery 30 days and 1 year after the procedure Yes

Sponsors