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

This study has been completed.
Sponsor:
Information provided by:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT00691314
First received: April 12, 2008
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Stroke
Transient Ischemic Attack
Atherosclerosis
Stenosis
Stents
Device: Stent implantation (Wingspan, Coroflex, and TiTAN2)
Drug: Standard medical treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Ischemic stroke in the supply area of stent implantation artery [ Time Frame: 30 days and 1 year after the procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hemorrhagic stroke [ Time Frame: 30 days and 1 year after the procedure ] [ Designated as safety issue: Yes ]
  • Ischemic stroke in the supply area of non-stent implantation artery [ Time Frame: 30 days and 1 year after the procedure ] [ Designated as safety issue: Yes ]
  • Acute coronary syndrome [ Time Frame: 30 days and 1 year after the procedure ] [ Designated as safety issue: Yes ]
  • All-cause death [ Time Frame: 30 days and 1 year after the procedure ] [ Designated as safety issue: Yes ]
  • Transient ischemic attack [ Time Frame: 30 days and 1 year after the procedure ] [ Designated as safety issue: Yes ]
  • Degree of re-stenosis of the stent implantation artery [ Time Frame: 30 days and 1 year after the procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: June 2008
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: 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

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)

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691314

Locations
China, Beijing
Xuanwu Hospital Capital Medical University
Beijing, Beijing, China, 100053
Beijing Tiantan Hospital
Beijing, Beijing, China, 100050
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
China, Chongqing
Daping Hospital
Chongqing, Chongqing, China, 400042
Southwest Hospital
Chongqing, Chongqing, China, 400038
China, Jiangsu
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu, China, 210002
China, Jilin
Jilin University
Changchun, Jilin, China, 130021
China, Shanghai
Huashan Hospital Fudan University
Shanghai, Shanghai, China, 200040
China, Sichuan
West China Center of Medical Sciences
Chengdu, Sichuan, China, 610041
China, Tianjin
The General Hospital Under Tianjin Medical Sciences University
Tianjin, Tianjin, China, 300052
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Liying Cui Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Liying Cui, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT00691314     History of Changes
Other Study ID Numbers: 2006BAI01A10-2
Study First Received: April 12, 2008
Last Updated: February 23, 2011
Health Authority: China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:
Stroke
Transietn Ischemic Attack
Stents
Stenosis

Additional relevant MeSH terms:
Constriction, Pathologic
Atherosclerosis
Arteriosclerosis
Ischemic Attack, Transient
Pathological Conditions, Anatomical
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014