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

Phase 2

Completed

• Conditions: Ischemic Stroke; Vertebral Artery Stenosis
• Interventions: Device: Drug eluting stent (DES); Device: Bare metal stent (BES)

• Registration Number: NCT03201432
• Lead Sponsor: Xiongjing Jiang

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2016-03-04
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-25
• Last Update Submitted: 2017-06-25
• Study First Posted: 2017-06-28
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug eluting stent (DES) group	Drug eluting stent (DES)	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) group	Bare metal stent (BES)	Percutaneous vertebral artery stenting using bare metal stents (Boston Scientific：Express SD) in patients randomized to BES group

Primary Outcome Measures

Name	Time	Method
Stent restenosis rate 6 months after stenting	6 months

Secondary Outcome Measures

Name	Time	Method
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