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

NCT ID: NCT03201432

Last Updated: 2017-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-01-31

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.

Conditions

Ischemic Stroke; Vertebral Artery Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bare metal stent (BES) group

Percutaneous vertebral artery stenting using bare metal stents (Boston Scientific：Express SD) in patients randomized to BES group

Group Type: OTHER

Bare metal stent (BES)

Intervention Type: DEVICE

Bare metal stent

Drug eluting stent (DES) group

Percutaneous vertebral artery stenting using drug eluting stents (Liaoning Biomedical Materials R\&D Center Co., Ltd. ：YINYI) in patients randomized to DES group

Group Type: EXPERIMENTAL

Drug eluting stent (DES)

Intervention Type: DEVICE

Polymer-free paclitaxel eluting stents

Interventions

Drug eluting stent (DES)

Polymer-free paclitaxel eluting stents

Intervention Type: DEVICE

Bare metal stent (BES)

Bare metal stent

Intervention Type: DEVICE

Other Intervention Names

YINYI (Liaoning Biomedical Materials R&D Center Co., Ltd.); Express SD (Bosten Scientific)

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yinyi(Liaoning) Biotech Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Xiongjing Jiang

OTHER

Sponsor Role: lead

Responsible Party

Xiongjing Jiang

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiongjing Jiang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Other Identifiers

2014-ZX15

Identifier Type: -

Identifier Source: org_study_id