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

NCT00691314 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2011-02-24

No results posted yet for this study

Summary

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

DEVICE

Stent implantation (Wingspan, Coroflex, and TiTAN2)

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

DRUG

Standard medical treatment

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)

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Liying Cui · Peking Union Medical College Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-09-30
Completion
2010-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00691314 on ClinicalTrials.gov