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Completed

NCT Number: NCT00691314

Efficacy and Safety 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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Standard Medical Treatment

Drug

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 outcomes

  1. Ischemic stroke in the supply area of stent implantation artery

    Time frame: 30 days and 1 year after the procedure

Secondary outcomes

  1. Hemorrhagic stroke

    Time frame: 30 days and 1 year after the procedure

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

    Time frame: 30 days and 1 year after the procedure

  3. Acute coronary syndrome

    Time frame: 30 days and 1 year after the procedure

  4. All-cause death

    Time frame: 30 days and 1 year after the procedure

  5. Transient ischemic attack

    Time frame: 30 days and 1 year after the procedure

  6. Degree of re-stenosis of the stent implantation artery

    Time frame: 30 days and 1 year after the procedure

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Acronym: ESSCAS

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 5, 2008
Registry last updated
Feb 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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