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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Atherosclerosis; Transient Ischemic Attack; Stenosis; Stents
• Intervention / Treatment: Device: Stent implantation (Wingspan, Coroflex, and TiTAN2); Drug: Standard medical treatment

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100050
      • Beijing Tiantan Hospital
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital Capital Medical University
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Southwest Hospital
    • Chongqing, Chongqing, China, 400042
      • Daping Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Nanjing General Hospital of Nanjing Military Command
  • Jilin
    • Changchun, Jilin, China, 130021
      • Jilin University
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Center of Medical Sciences
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • The General Hospital Under Tianjin Medical Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 2	Drug: 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)
EXPERIMENTAL: 1	Device: Stent implantation (Wingspan, Coroflex, and TiTAN2); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ischemic stroke in the supply area of stent implantation artery	30 days and 1 year after the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Degree of re-stenosis of the stent implantation artery	30 days and 1 year after the procedure

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: April 12, 2008
• First Submitted That Met QC Criteria: June 4, 2008
• First Posted (ESTIMATE): June 5, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): February 24, 2011
• Last Update Submitted That Met QC Criteria: February 23, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Stroke; Stents; Stenosis; Transietn Ischemic Attack
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Brain Ischemia; Ischemic Attack, Transient; Constriction, Pathologic; Atherosclerosis
• Other Study ID Numbers: 2006BAI01A10-2