Back to resultsEfficacy and Safety of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis (ESSCAS)
Primary Purpose
Stroke, Transient Ischemic Attack, Atherosclerosis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stent implantation (Wingspan, Coroflex, and TiTAN2)
Standard medical treatment
Sponsored by
About this trial
This is an interventional prevention trial for Stroke focused on measuring Stroke, Transietn Ischemic Attack, Stents, Stenosis
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.
- 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.
Sites / Locations
- Beijing Tiantan Hospital
- Xuanwu Hospital Capital Medical University
- Peking Union Medical College Hospital
- Southwest Hospital
- Daping Hospital
- Nanjing General Hospital of Nanjing Military Command
- Jilin University
- Huashan Hospital Fudan University
- West China Center of Medical Sciences
- The General Hospital Under Tianjin Medical Sciences University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Ischemic stroke in the supply area of stent implantation artery
Secondary Outcome Measures
Hemorrhagic stroke
Ischemic stroke in the supply area of non-stent implantation artery
Acute coronary syndrome
All-cause death
Transient ischemic attack
Degree of re-stenosis of the stent implantation artery
Full Information
NCT ID
NCT00691314
First Posted
April 12, 2008
Last Updated
February 23, 2011
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00691314
Brief Title
Efficacy and Safety of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis
Acronym
ESSCAS
Official Title
Safety and Efficacy of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Transient Ischemic Attack, Atherosclerosis, Stenosis, Stents
Keywords
Stroke, Transietn Ischemic Attack, Stents, Stenosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Stent implantation (Wingspan, Coroflex, and TiTAN2)
Intervention Description
Stent Implantation:
Wingspan intracranial stent with Gateway PTA balloon Catheter; Coroflex® - 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
Drug
Intervention Name(s)
Standard medical treatment
Intervention Description
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)
Primary Outcome Measure Information:
Title
Ischemic stroke in the supply area of stent implantation artery
Time Frame
30 days and 1 year after the procedure
Secondary Outcome Measure Information:
Title
Hemorrhagic stroke
Time Frame
30 days and 1 year after the procedure
Title
Ischemic stroke in the supply area of non-stent implantation artery
Time Frame
30 days and 1 year after the procedure
Title
Acute coronary syndrome
Time Frame
30 days and 1 year after the procedure
Title
All-cause death
Time Frame
30 days and 1 year after the procedure
Title
Transient ischemic attack
Time Frame
30 days and 1 year after the procedure
Title
Degree of re-stenosis of the stent implantation artery
Time Frame
30 days and 1 year after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liying Cui
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Daping Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Nanjing General Hospital of Nanjing Military Command
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Huashan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
West China Center of Medical Sciences
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
The General Hospital Under Tianjin Medical Sciences University
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
12. IPD Sharing Statement
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Efficacy and Safety of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis
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