Actively Recruiting

Age: 18Years - 90Years
All Genders
ID03999983

Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)

Led by St. Louis University · Updated on 2025-02-12

150

Participants Needed

10

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates patients who have experienced a stroke and have evidence of narrowing in the vertebral artery origin, a condition known as Vertebral Artery Origin Stenosis (VAOS). The study collects information from both past and current patients to better understand clinical outcomes following treatment for this condition. It focuses on patients who have had a posterior circulation ischemic event and confirmed artery disease, aiming to evaluate the results of different management approaches over time. The study includes a registry that tracks patients who underwent stenting along with medical management to prevent another stroke. It gathers data on clinical outcomes up to 18 months after treatment. Originally designed as a prospective registry, the study changed to a retrospective format in January 2025, meaning it now collects and analyzes information from past cases rather than following patients forward in time. Participants' health data, including clinical and angiographic outcomes, are collected at 30 days and one year after treatment. Researchers measure the incidence of recurrent stroke or death within one year post-treatment and also track the occurrence of artery narrowing returning (restenosis). The study lasts up to 18 months post-treatment, during which participants' progress and outcomes are monitored to understand the effectiveness and safety of the treatments used.

CONDITIONS

Brief Title

Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 more than 50% stenosis on the side being targeted for therapy
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Contrast indication to the use of anti-platelet drugs
  • There is tandem vertebral or basilar artery stenosis
  • Serum creatinine is greater than 2.5
  • Baseline modified Rankin score is greater than 3
  • Life expectancy less than 5 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 18 months post-treatment

Participants who have undergone stenting plus medical management for vertebral artery origin stenosis are observed to collect information on clinical and angiographic outcomes.

Visits at 30 days and 1 year post-treatment

Trial Site Locations

Total: 10 locations

1

Baptist Medical Center Jacksonville

Jacksonville, Florida, United States, 32207

Actively Recruiting

2

University of Southern Florida

Tampa, Florida, United States, 33606

Actively Recruiting

3

Northwestern Medicine Regional Medical Group

Winfield, Illinois, United States, 60190

Actively Recruiting

4

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

5

SSM DePaul Hospital

Bridgeton, Missouri, United States, 63044

Actively Recruiting

6

Saint Louis University

St Louis, Missouri, United States, 63110

Actively Recruiting

7

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Not Yet Recruiting

8

Mercy Health Neuroscience Institute

Toledo, Ohio, United States, 43608

Actively Recruiting

9

Semmes Murphey Clinic

Memphis, Tennessee, United States, 38120

Actively Recruiting

10

Texas Tech University Health Science Center of El Paso

El Paso, Texas, United States, 79905

Not Yet Recruiting

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Research Team

R

Randall Edgell, MD

M

Mollie Hoffmeyer, RN, BSN

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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