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| Name | Class |
|---|---|
| Yinyi(Liaoning) Biotech Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bare metal stent (BES) group | Other | Percutaneous vertebral artery stenting using bare metal stents (Boston Scientific:Express SD) in patients randomized to BES group |
|
| Drug eluting stent (DES) group | Experimental | Percutaneous vertebral artery stenting using drug eluting stents (Liaoning Biomedical Materials R&D Center Co., Ltd. :YINYI) in patients randomized to DES group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug eluting stent (DES) | Device | Polymer-free paclitaxel eluting stents |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stent restenosis rate 6 months after stenting | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stent restenosis rate 3 months after stenting | 3 months | |
| Stent restenosis rate 12 months after stenting | measured by ultrasound | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiongjing Jiang, M.D. | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D014715 | Vertebrobasilar Insufficiency |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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No Masking
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| Bare metal stent (BES) | Device | Bare metal stent |
|
|
| The incidence of cardiovascular events (stroke, TIA, Miocardial infarction and death) 6 months after stenting | 6 months |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |