NCT00691314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable stroke

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 24, 2011

Status Verified

February 1, 2011

Enrollment Period

2.3 years

First QC Date

April 12, 2008

Last Update Submit

February 23, 2011

Conditions

StrokeTransient Ischemic AttackAtherosclerosisStenosisStents

Keywords

StrokeTransietn Ischemic AttackStentsStenosis

Outcome Measures

Primary Outcomes (1)

  • Ischemic stroke in the supply area of stent implantation artery

    30 days and 1 year after the procedure

Secondary Outcomes (6)

  • Hemorrhagic stroke

    30 days and 1 year after the procedure

  • Ischemic stroke in the supply area of non-stent implantation artery

    30 days and 1 year after the procedure

  • Acute coronary syndrome

    30 days and 1 year after the procedure

  • All-cause death

    30 days and 1 year after the procedure

  • Transient ischemic attack

    30 days and 1 year after the procedure

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Device: Stent implantation (Wingspan, Coroflex, and TiTAN2)

2

ACTIVE COMPARATOR
Drug: Standard medical treatment

Interventions

Stent implantation (Wingspan, Coroflex, and TiTAN2)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

1
Standard medical treatmentDRUG

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)

2

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Concurrent participation in another clinical trial
  • Unable to return follow up
  • History of hemorrhagic disease(ie, intracranial hemorrhage, Idiopathic Thrombocytopenic Purpura,etc ) or bleeding tendency conditions.
  • Intracranial arteriovenous malformation or aneurysm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

Location

Daping Hospital

Chongqing, Chongqing Municipality, 400042, China

Location

Nanjing General Hospital of Nanjing Military Command

Nanjing, Jiangsu, 210002, China

Location

Jilin University

Changchun, Jilin, 130021, China

Location

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

West China Center of Medical Sciences

Chengdu, Sichuan, 610041, China

Location

The General Hospital Under Tianjin Medical Sciences University

Tianjin, Tianjin Municipality, 300052, China

Location

MeSH Terms

Conditions

StrokeIschemic Attack, TransientAtherosclerosisConstriction, Pathologic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaArteriosclerosisArterial Occlusive DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Liying Cui

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2008

First Posted

June 5, 2008

Study Start

June 1, 2008

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

February 24, 2011

Record last verified: 2011-02

Locations

CN(10)