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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03201432
• Other study ID #: 2014-ZX15
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 4, 2016
• Last updated: June 25, 2017
• Start date: May 2014
• Est. completion date: January 2017

Study information

• Verified date: June 2017
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Ischemic Stroke
• Vertebral Artery Stenosis
• Vertebrobasilar Insufficiency

Intervention

Device:
• Drug eluting stent (DES)
Polymer-free paclitaxel eluting stents
• Bare metal stent (BES)
Bare metal stent

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Xiongjing Jiang	Liaoning Biomedical Materials R&D Center Co., Ltd.

Outcome

Type	Measure	Description	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	measured by ultrasound	12 months
Secondary	The incidence of cardiovascular events (stroke, TIA, Miocardial infarction and death) 6 months after stenting		6 months