Ischemic Stroke, Vertebral Artery Stenosis
Conditions
Keywords
Vertebral Artery Stenosis, Ischemic Stroke, Stent
Brief summary
Stroke is one of the important causes of disability and death in the world, in which more than half were ischemic strokes. About 1/4 of the ischemic stroke occurred in the vertebral basilar artery system, especially when in the presence of extracranial proximal vertebral artery stenosis. Vertebral artery stenting is a minimally invasive method for the reconstruction of vertebral artery stenosis and the early clinical studies showed that it was feasible, safe and effective, but the high rate of restenosis has become a bottleneck restricting its development. Previous systematic review had suggested that the drug eluting stent might reduce the incidence of restenosis of vertebral artery. However, prospective randomized controlled trials comparing the efficacy of bare metal stents and drug eluting stents on the prevention of restenosis remains absent.
Detailed description
60 patients were randomly assigned into DES and BES group to compare the safety and efficacy in the treatment of symptomatic extracranial vertebral artery stenosis with drug eluting stents (YINYI) and bare metal stents (Express SD), especially the stent restenosis rate after 6 months.
Interventions
DEVICEDrug eluting stent (DES)
Polymer-free paclitaxel eluting stents
DEVICEBare metal stent (BES)
Bare metal stent
Sponsors
Yinyi(Liaoning) Biotech Co., Ltd.
Xiongjing Jiang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No Masking
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic posterior circulation ischemia（Vertebral basilar artery system TIA or non-disabling ischemic stroke）result from the stenosis in the extracranial proximal vertebral artery stenosis. * Atherosclerotic extracranial proximal vertebral artery stenosis demonstrated by angiography(any of the following): 1) bilateral vertebral artery stenosis ≥70%, or vertebral artery stenosis ≥70% concomitant occlusion of contralateral vertebral artery; 2) superior lateral vertebral artery stenosis ≥70%; 3) non-superior lateral vertebral artery stenosis ≥50%, but the vertebral artery was directly extended to the posterior inferior cerebellar artery on this side and symptoms were related to insufficiency of the ipsilateral posterior inferior cerebellar artery.
Exclusion criteria
* 1\) lesions characteristics (such as diffuse lesions) which was not suitable for interventional treatment, or unstable condition that cannot tolerate the interventional therapy; * 2\) vertebral artery stenosis caused by non atherosclerosis disease: Takayasu arteritis or other diseases; * 3\) severe stroke within 3 months; * 4\) contraindicated using contrast agents: such as chronic renal insufficiency or had serious contrast agents allergy history; * 5\) malignant tumor; * 6\) with Alzheimer's disease or mental illness previously or currently ; * 7\) patients or family members refuse the operation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stent restenosis rate 6 months after stenting | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent restenosis rate 3 months after stenting | 3 months | — |
| Stent restenosis rate 12 months after stenting | 12 months | measured by ultrasound |
| The incidence of cardiovascular events (stroke, TIA, Miocardial infarction and death) 6 months after stenting | 6 months | — |
Outcome results
None listed