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Recruiting NCT03999983

Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)

Observational Vertebral Artery Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational Prospective Registry.
Who it may be relevant to
Registry conditions: Vertebral Artery Stenosis. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

A retrospective and prospective registry of patients admitted for stroke and evidence of Vertebral Artery Origin Stenosis (VAOS).

Detailed description

A retrospective registry of stenting plus medical management for the prevention of recurrent stroke in patients with symptomatic Vertebral Artery origin Stenosis (VAOS). This study is collecting information on clinical outcomes up to 18 months post-treatment.

On January 6, 2025, VOTER was changed from prospective to retrospective.

Interventions

  • Other Observational Prospective Registry
    This is a prospective registry looking at patients admitted for stroke with evidence of Vertebral Artery Origin Stenosis. Patients clinical outcomes will be collected at 30 days and 1-year post-treatment and angiographic outcomes at 1-year post-treatment

Primary outcome measures

  • Incidence of recurrent stroke or death [Time frame: 1 Year post-treatment]
Secondary outcome measures (1)
  • Incidence of Restenosis [Time frame: 1 Year post-treatment]

Eligibility criteria

Inclusion criteria

  • Patients between 18 and 90 years of age
  • Patient has experienced a posterior circulation ischemic event
  • Patient has angiographically confirmed bilateral vertebral artery origin disease (Hypoplasia, occlusion, or stenosis).
  • Patient has >50% stenosis on the side being targeted for therapy

Exclusion criteria

  • Pregnant women
  • Contrast Indication to the use of anti-platelet drugs
  • There is tandem vertebral or basilar artery stenosis
  • The serum creatinin is >2.5
  • Baseline modified Rankin score is >3
  • < 5 years life expectancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 10 centers
  • Baptist Medical Center Jacksonville — Jacksonville
  • University of Southern Florida — Tampa
  • Northwestern Medicine Regional Medical Group — Winfield
  • University of Iowa — Iowa City
  • SSM DePaul Hospital — Bridgeton
  • Saint Louis University — St Louis
  • Cleveland Clinic — Cleveland
  • Mercy Health Neuroscience Institute — Toledo
  • … and 2 more centers

Identifiers

NCT: NCT03999983 · 29760

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗