Drug Eluting Stents Versus Bare Metal Stents for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis

Completed

Phase 2/3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Drug eluting stent (DES) Device
    Other Names: YINYI (Liaoning Biomedical Materials R&D Center Co., Ltd.)
    Intervention Desc: Polymer-free paclitaxel eluting stents
    ARM 1: Kind: Experimental
    Label: Drug eluting stent (DES) group
    Description: Percutaneous vertebral artery stenting using drug eluting stents (Liaoning Biomedical Materials R&D Center Co., Ltd. :YINYI) in patients randomized to DES group
  • Bare metal stent (BES) Device
    Other Names: Express SD (Bosten Scientific)
    Intervention Desc: Bare metal stent
    ARM 1: Kind: Experimental
    Label: Bare metal stent (BES) group
    Description: Percutaneous vertebral artery stenting using bare metal stents (Boston Scientific:Express SD) in patients randomized to BES group

Outcomes

Type Measure Time Frame Safety Issue
Primary Stent restenosis rate 6 months after stenting 6 months
Secondary Stent restenosis rate 3 months after stenting 3 months
Secondary Stent restenosis rate 12 months after stenting 12 months
Secondary The incidence of cardiovascular events (stroke, TIA, Miocardial infarction and death) 6 months after stenting 6 months

Sponsors