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StrokeESSCASNCT00691314

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

A study testing Stent implantation (Wingspan, Coroflex, and TiTAN2) and Standard medical treatment in people with Stroke and Transient Ischemic Attack, run by Peking Union Medical College Hospital at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Stroke, Transient Ischemic Attack, Atherosclerosis
What is being tested?
Stent implantation (Wingspan, Coroflex, and TiTAN2) and Standard medical treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
10 sitesChina
Study dates
Jun 2008to Dec 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 14Show fewer
  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100050

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Jilin University

    Changchun, Jilin, 130021

  • West China Center of Medical Sciences

    Chengdu, Sichuan, 610041

  • Southwest Hospital

    Chongqing, Chongqing Municipality, 400038

  • Daping Hospital

    Chongqing, Chongqing Municipality, 400042

  • Nanjing General Hospital of Nanjing Military Command

    Nanjing, Jiangsu, 210002

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040

  • The General Hospital Under Tianjin Medical Sciences University

    Tianjin, Tianjin Municipality, 300052

Other trials in China

About this study

Official title: 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.

Being tested
Stent implantation (Wingspan, Coroflex, and TiTAN2), Standard medical treatment
Keywords
Stroke, Transietn Ischemic Attack, Stents, Stenosis
Medical subject headings
Stroke, Ischemic Attack, Transient, Atherosclerosis, Constriction, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 treatmentDrug

    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)

Study groups in NCT00691314
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Device: Stent implantation (Wingspan, Coroflex, and TiTAN2)
2Active comparatorNot described
Receives: Drug: Standard medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 30 days and 1 year after the procedure

Secondary outcomes (6)

  1. Hemorrhagic stroke

    Measured: 30 days and 1 year after the procedure

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

    Measured: 30 days and 1 year after the procedure

  3. Acute coronary syndrome

    Measured: 30 days and 1 year after the procedure

  4. All-cause death

    Measured: 30 days and 1 year after the procedure

  5. Transient ischemic attack

    Measured: 30 days and 1 year after the procedure

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

    Measured: 30 days and 1 year after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionSep 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00691314
Sponsor's protocol ID
2006BAI01A10-2
Acronym
ESSCAS
Status last verified
Feb 2011
First submitted
12 Apr 2008
Last updated
24 Feb 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Stent implantation (Wingspan, Coroflex, and TiTAN2) and Standard medical treatment in people with Stroke and Transient Ischemic Attack, run by Peking Union Medical College Hospital at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ischemic stroke in the supply area of stent implantation artery (time frame: 30 days and 1 year after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00691314.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2011.

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