Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER) (VOTER)

January 12, 2024 updated by: Randall C. Edgell, MD, FSVIN, St. Louis University
A prospective registry of patients admitted for stroke and evidence of Vertebral Artery Origin Stenosis (VAOS).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective registry of stenting plus medical management for the prevention of recurrent stroke in patients with symptomatic Vertebral Artery origin Stenosis (VAOS). Looking at clinical outcomes at 30 days and 1-year post-treatment and angiographic outcomes at 1-year post-treatment.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center Jacksonville
      • Tampa, Florida, United States, 33606
        • University of Southern Florida
    • Illinois
      • Winfield, Illinois, United States, 60190
        • Northwestern Medicine Regional Medical Group
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • SSM DePaul Hospital
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Toledo, Ohio, United States, 43608
        • Mercy Health Neuroscience Institute
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Semmes Murphey Clinic
    • Texas
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health Science Center of El Paso

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted for stroke and evidence of Vertebral Artery Origin Stenosis (VAOS).

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnant women
  2. Contrast Indication to the use of anti-platelet drugs
  3. There is tandem vertebral or basilar artery stenosis
  4. The serum creatinin is >2.5
  5. Baseline modified Rankin score is >3
  6. < 5 years life expectancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of recurrent stroke or death
Time Frame: 1 Year post-treatment
Recurrent stroke of any type or death from any cause
1 Year post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Restenosis
Time Frame: 1 Year post-treatment
Restenosis in VAOS patients treated with drug-eluting stents.
1 Year post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Louis University

Investigators

  • Principal Investigator: Randall Edgell, MD, St. Louis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2019

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

June 25, 2019

First Posted (Actual)

June 27, 2019

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29760

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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