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

A Randomized Trial for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis: Drug Eluting Stents Versus Bare Metal Stents

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke; Vertebral Artery Stenosis
• Intervention / Treatment: Device: Bare metal stent (BES); Device: Drug eluting stent (DES)

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Bare metal stent (BES) group; Percutaneous vertebral artery stenting using bare metal stents (Boston Scientific：Express SD) in patients randomized to BES group	Device: Bare metal stent (BES); Bare metal stent; Other Names: Express SD (Bosten Scientific)
Experimental: 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	Device: Drug eluting stent (DES); Polymer-free paclitaxel eluting stents; Other Names: YINYI (Liaoning Biomedical Materials R&D Center Co., Ltd.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Stent restenosis rate 6 months after stenting	6 months

Secondary Outcome Measures

Outcome Measure	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
The incidence of cardiovascular events (stroke, TIA, Miocardial infarction and death) 6 months after stenting		6 months

Collaborators and Investigators

• Sponsor: Xiongjing Jiang
• Collaborators: Yinyi(Liaoning) Biotech Co., Ltd.
• Investigators: Principal Investigator: Xiongjing Jiang, M.D., Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: June 25, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 25, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Stent; Ischemic Stroke; Vertebral Artery Stenosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Brain Ischemia; Stroke; Ischemic Stroke; Constriction, Pathologic; Vertebrobasilar Insufficiency
• Other Study ID Numbers: 2014-ZX15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No