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

Peking Union Medical College Hospital10 sites in 1 country300 target enrollmentJune 2008

ConditionsStroke Transient Ischemic Attack Atherosclerosis Stenosis Stents

InterventionsStent implantation (Wingspan, Coroflex, and TiTAN2)Standard medical treatment

DrugsStandard medical treatment

Overview

Phase: N/A
Intervention: Stent implantation (Wingspan, Coroflex, and TiTAN2)
Conditions: Stroke
Sponsor: Peking Union Medical College Hospital
Enrollment: 300
Locations: 10
Primary Endpoint: Ischemic stroke in the supply area of stent implantation artery
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

December 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

•Aged between above 40 year-old and 75 year-old.
•Ischemic stroke related to extra- and intracranial atherosclerosis stenosis, transient ischemic attack (TIA ), onset time within 90 days
•Implantation of stent should be at least 1 week after stroke onset, and patient's medical condition stable, no time limit for TIA,
•Stenosed ICA or MCA or BA or VA is the candidate arteries for stent implantation.
•Degree of stenosis of target artery ranges between 51%-99%
•Modified Rankin score≤3 or NIHSS Score ≤4
•Informed consent is obtained.

Exclusion Criteria

•Patients will be excluded from entry if any of the criteria listed below are met:
•Target stenosis artery is not suitable for stent implantation after evaluation.
•Previous carotid endarterectomy or carotid artery stent ,or intracranial artery stent implantation.
•Ischemic stroke is caused by conditions other than atherosclerosis .
•Documented non-atherosclerosis angiopathy.
•Clinically unstable at the time of enrollment,
•Conditions which may lead to cardiogenic embolism : arterial fibrillation，left ventricular thrombi,Myocardiac infarction within 6 weeks,etc.
•Severe hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg)
•Severe co-morbid or unstable medical condition, ie，severe heart failure, pulmonary failure or renal failure, liver dysfunction (serum liver enzyme twice or more than normal level),malignancy with likelihood of death within the next 2 years
•Significant memory or behavioral disorder, ie, Alzheimer disease, etc.daily care needed.

Arms & Interventions

1

Intervention: Stent implantation (Wingspan, Coroflex, and TiTAN2)

2

Intervention: Standard medical treatment

Outcomes

Primary Outcomes

Ischemic stroke in the supply area of stent implantation artery

Time Frame: 30 days and 1 year after the procedure

Secondary Outcomes

Ischemic stroke in the supply area of non-stent implantation artery(30 days and 1 year after the procedure)
All-cause death(30 days and 1 year after the procedure)
Hemorrhagic stroke(30 days and 1 year after the procedure)
Acute coronary syndrome(30 days and 1 year after the procedure)
Transient ischemic attack(30 days and 1 year after the procedure)
Degree of re-stenosis of the stent implantation artery(30 days and 1 year after the procedure)