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Enterprise Stent Implantation in the Treatment of Carotid Artery Stenosis With Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02802072
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : June 16, 2016
Information provided by (Responsible Party):
Meng Ji, Beijing Chao Yang Hospital

Brief Summary:
To investigate the long-term effects of intracranial implantation of Enterprise stent system versus antiplatelet medication on neurologic deficits, daily living abilities, and carotid artery stenosis in patients with atherosclerotic ischemic stroke.

Condition or disease Intervention/treatment Phase
Carotid Artery Stenosis Device: Enterprise stent implantation Drug: Only aspirin medication Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Long-term Effects of Enterprise Self-expanding Intracranial Stent Implantation in the Treatment of Carotid Artery Stenosis in Patients With Ischemic Stroke: Study Protocol for a Randomized Controlled Trial
Study Start Date : January 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Enterprise stent implantation group
Patients with atherosclerotic ischemic stroke will be randomly allocated to receive Enterprise stent implantation in combination with antiplatelet medication for carotid artery stenosis.
Device: Enterprise stent implantation
Enterprise stent system (Johnson & Johnson (Shanghai) Medical Equipment Co.,Ltd., China) is a closed loop self-expanding stent system that is made of Ni-Ti alloy. It consists of a self-expanding stent and a delivery system.
Other Name: Enterprise self-expanding stent system implantation

Experimental: Only aspirin medication group
Patients with atherosclerotic ischemic stroke will be randomly allocated to receive only antiplatelet medication for carotid artery stenosis.
Drug: Only aspirin medication
Only aspirin medication will be conducted, initial dose is 300 mg/d, 200 mg/d 6 months later, and 100 mg/d 1 year later.
Other Name: Drug intervention

Primary Outcome Measures :
  1. National Institutes of Health Stroke Scale score [ Time Frame: 1 year after treatment ]
    Patient's neurologic deficits will be evaluated with the National Institutes of Health Stroke Scale (NIHSS) score 1 year after stent implantation or antiplatelet medication or antiplatelet medication only.

Secondary Outcome Measures :
  1. Changes of Barthel index [ Time Frame: 0.5, 1, 2, 3 years after treatment ]
    To evaluate patient's activities of daily living

  2. Carotid stenosis rate [ Time Frame: 1 year after treatment ]
    Following digital subtraction angiography examination (Siemens), Seldinger-guided femoral artery cannulation will be performed. Selective angiography will be conducted to harvest bilateral carotid artery images from the anterior-posterior, oblique and lateral views. Carotid stenosis rate = (diameter of distal stenotic segment - diameter of narrowest segment)/diameter of distal stenotic segment × 100%.

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Ages Eligible for Study:   17 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Atherosclerotic plague-caused carotid artery stenosis
  • Severe carotid artery stenosis (unilateral stenosis > 70%) diagnosed according to angiography
  • Age 18-75 years
  • Of either sex
  • Provision of informed consent regarding trial procedure

Exclusion Criteria:

  • Non-atherosclerotic intracranial artery stenosis
  • Severe cognitive or mental disorder
  • Severe cardiovascular, hepatic, renal, or blood system diseases
  • Pregnant or lactating
  • Hemorrhagic disease or unable to receive anticoagulation or antiplatelet aggregation treatment
  • Allergy to stent material
  • Unable to or declined to cooperate with follow-up examination
  • Unable to provide informed consent because of intellectual disability or language disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02802072

Sponsors and Collaborators
Beijing Chao Yang Hospital
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Principal Investigator: Meng Ji, Ph.D. Beijing Chao Yang Hospital, China
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Responsible Party: Meng Ji, Attending Physician, Beijing Chao Yang Hospital Identifier: NCT02802072    
Other Study ID Numbers: BeijingCYH_001
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Carotid Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors