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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke Transient Ischemic Attack Atherosclerosis Stenosis Stents

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Stent implantation (Wingspan, Coroflex, and TiTAN2)

Intervention Type DEVICE

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

2

Group Type ACTIVE_COMPARATOR

Standard medical treatment

Intervention Type DRUG

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)

Interventions

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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

Intervention Type DEVICE

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)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Patients will be excluded from entry if any of the criteria listed below are met:

1. Target stenosis artery is not suitable for stent implantation after evaluation.
2. Previous carotid endarterectomy or carotid artery stent ,or intracranial artery stent implantation.
3. Ischemic stroke is caused by conditions other than atherosclerosis .
4. Documented non-atherosclerosis angiopathy.
5. Clinically unstable at the time of enrollment,
6. Conditions which may lead to cardiogenic embolism : arterial fibrillation，left ventricular thrombi,Myocardiac infarction within 6 weeks,etc.
7. Severe hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg)
8. 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
9. Significant memory or behavioral disorder, ie, Alzheimer disease, etc.daily care needed.
10. Concurrent participation in another clinical trial
11. Unable to return follow up
12. History of hemorrhagic disease(ie, intracranial hemorrhage, Idiopathic Thrombocytopenic Purpura,etc ) or bleeding tendency conditions.
13. Intracranial arteriovenous malformation or aneurysm.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No