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Efficacy and Safety of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis (ESSCAS)
This study is currently recruiting participants.
Study NCT00691314   Information provided by Peking Union Medical College Hospital
First Received: April 12, 2008   Last Updated: September 17, 2009   History of Changes

April 12, 2008
September 17, 2009
June 2008
July 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00691314 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Efficacy and Safety of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis
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.

 
 
Interventional
Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
  • Stroke
  • Transient Ischemic Attack
  • Atherosclerosis
  • Stenosis
  • Stents
  • Device: Stent implantation (Wingspan, Coroflex, and TiTAN2)
  • Drug: Standard medical treatment
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
400
August 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
40 Years to 75 Years
No
Contact: Liying Cui 86-10-65296373 pumchcly@yahoo.com.cn
Contact: Bin Peng 86-10-65296371 pengbin3@hotmail.com
China
 
NCT00691314
Liying Cui, Peking Union Medical College Hospital
2006BAI01A10-2
Peking Union Medical College Hospital
 
Principal Investigator: Liying Cui Peking Union Medical College Hospital
Peking Union Medical College Hospital
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP