Clinical Trials Directory

Trials / Completed

CompletedNCT00691314

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
300 (estimated)
Sponsor
Peking Union Medical College Hospital · Academic / Other
Sex
All
Age
40 Years – 75 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
DEVICEStent 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
DRUGStandard medical treatmentStandard 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)

Timeline

Start date
2008-06-01
Primary completion
2010-09-01
Completion
2010-12-01
First posted
2008-06-05
Last updated
2011-02-24

Locations

10 sites across 1 country: China

Source: ClinicalTrials.gov record NCT00691314. Inclusion in this directory is not an endorsement.