Enterprise Stent Implantation in the Treatment of Carotid Artery Stenosis With Ischemic Stroke
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|ClinicalTrials.gov Identifier: NCT02802072|
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : June 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Carotid Artery Stenosis||Device: Enterprise stent implantation Drug: Only aspirin medication||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- 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.
- Changes of Barthel index [ Time Frame: 0.5, 1, 2, 3 years after treatment ]To evaluate patient's activities of daily living
- 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%.
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 ClinicalTrials.gov identifier (NCT number): NCT02802072
|Principal Investigator:||Meng Ji, Ph.D.||Beijing Chao Yang Hospital, China|