NCT03201432

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

2.7 years

First QC Date

March 4, 2016

Last Update Submit

June 25, 2017

Conditions

Ischemic StrokeVertebral Artery Stenosis

Keywords

Vertebral Artery StenosisIschemic StrokeStent

Outcome Measures

Primary Outcomes (1)

  • Stent restenosis rate 6 months after stenting

    6 months

Secondary Outcomes (3)

  • Stent restenosis rate 3 months after stenting

    3 months

  • Stent restenosis rate 12 months after stenting

    12 months

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

    6 months

Study Arms (2)

Bare metal stent (BES) group

OTHER

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

Device: Bare metal stent (BES)

Drug eluting stent (DES) group

EXPERIMENTAL

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)

Interventions

Drug eluting stent (DES)DEVICE

Polymer-free paclitaxel eluting stents

Also known as: YINYI (Liaoning Biomedical Materials R&D Center Co., Ltd.)
Drug eluting stent (DES) group
Bare metal stent (BES)DEVICE

Bare metal stent

Also known as: Express SD (Bosten Scientific)
Bare metal stent (BES) group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \) lesions characteristics (such as diffuse lesions) which was not suitable for interventional treatment, or unstable condition that cannot tolerate the interventional therapy;
  • \) vertebral artery stenosis caused by non atherosclerosis disease: Takayasu arteritis or other diseases;
  • \) severe stroke within 3 months;
  • \) contraindicated using contrast agents: such as chronic renal insufficiency or had serious contrast agents allergy history;
  • \) malignant tumor;
  • \) with Alzheimer's disease or mental illness previously or currently ;
  • \) patients or family members refuse the operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ischemic StrokeVertebrobasilar Insufficiency

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Xiongjing Jiang, M.D.

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No Masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 4, 2016

First Posted

June 28, 2017

Study Start

May 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

June 28, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share