Enterprise Stent Implantation in the Treatment of Carotid Artery Stenosis With Ischemic Stroke
|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|
Show Detailed Description
|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%.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802072
|Principal Investigator:||Meng Ji, Ph.D.||Beijing Chao Yang Hospital, China|