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NCT Number: NCT03999983

Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)

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

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Key information

Conditions

Vertebral Artery Stenosis Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases Vertebrobasilar Insufficiency

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baptist Medical Center Jacksonville, Jacksonville, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational Prospective Registry

Other

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

Other names: Observational

Primary outcomes

  1. Incidence of recurrent stroke or death

    Time frame: 1 Year post-treatment

    Recurrent stroke of any type or death from any cause

Secondary outcomes

  1. Incidence of Restenosis

    Time frame: 1 Year post-treatment

    Restenosis in VAOS patients treated with drug-eluting stents.

Study contacts

Contact information is provided by the study sponsor or research team.

Mollie Hoffmeyer, RN, BSN

CONTACT

[email protected]

314-617-3313

Randall Edgell, MD

CONTACT

[email protected]

314-977-3129

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Acronym: VOTER

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2019
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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