Vertebral Artery StenosisVOTERNCT03999983
Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)
An observational study of Vertebral Artery Stenosis, run by St. Louis University at 10 sites in United States.
Trial summary
A retrospective and prospective registry of patients admitted for stroke and evidence of Vertebral Artery Origin Stenosis (VAOS). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Vertebral Artery Stenosis
- What is being tested?
- Observational Prospective Registry
- How many people
- 150 participants
- Where
- 10 sitesUnited States
- Study dates
- 19 Nov 2019to Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted for stroke and evidence of Vertebral Artery Origin Stenosis (VAOS).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
SSM DePaul Hospital
Bridgeton, Missouri, 63044
Makenzie Woodford, BS, +1 (314) 344-6195, makenzie.woodford@ssmhealth.com
Amer Alsheklee, MD
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Lauren Todd, 216-442-5676, TOODL2@ccf.org
Gabor Toth, MD
- Not yet recruiting
Texas Tech University Health Science Center of El Paso
El Paso, Texas, 79905
Israel Alba, israel.alba@ttuhsc.edu
Vikas Gupta, MD
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Santiago Ortega, MD, MS, santy-ortega@uiowa.edu
Santy Ortega-Gutierrez, MD
- Recruiting
Baptist Medical Center Jacksonville
Jacksonville, Florida, 32207
Nancy Ebreo, CCRC,RRT,CRA, Nancy.ebreo@bmcjax.com
Nima Aghaebrahim, MD
- Recruiting
Semmes Murphey Clinic
Memphis, Tennessee, 38120
Amanda Nolte, annolte@semmes-murphey.com
Lucas Elijovich, MD
- Recruiting
Saint Louis University
St Louis, Missouri, 63110
Kara Christopher, MS, MPH, PhD, 314-977-3211, andre.guthrie@health.slu.edu
Benjamin Cummins, MPH/MPA, 314-977-3229, benjamin.cummins.1@health.slu.edu
- Recruiting
University of Southern Florida
Tampa, Florida, 33606
Waldo Guerrero, MD, wrguerre@usf.edu
Amy Denardo, amydenardo@usf.edu
- Recruiting
Mercy Health Neuroscience Institute
Toledo, Ohio, 43608
Kristine Below, KBelow@mercy.com
Osama Zaidat, MD
- Recruiting
Northwestern Medicine Regional Medical Group
Winfield, Illinois, 60190
Dhruvil Pandya, MD, dhruvil.pandya2@nm.org
Dhruvil Pandya, MD
About this study
A retrospective and prospective registry of patients admitted for stroke and evidence of Vertebral Artery Origin Stenosis (VAOS).
Read the 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.
- Conditions
- Vertebral Artery Stenosis
- Being tested
- Observational Prospective Registry
- Medical subject headings
- Vertebrobasilar Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Prospective RegistryOther
Also called Observational
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of recurrent stroke or death
Recurrent stroke of any type or death from any cause
Measured: 1 Year post-treatment
Secondary outcomes (1)
Incidence of Restenosis
Restenosis in VAOS patients treated with drug-eluting stents.
Measured: 1 Year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start19 Nov 2019
- Primary completionMar 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall C. Edgell, MD, FSVIN, St. Louis University
- Investigators
- Randall Edgell, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999983
- Sponsor's protocol ID
- 29760
- Acronym
- VOTER
- Status last verified
- Feb 2025
- First submitted
- 25 Jun 2019
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)
- ClinicalTrials.gov ID
- NCT03999983
- Acronym / sponsor ID
- VOTER / 29760
- Conditions
- Vertebral Artery Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for stroke and evidence of Vertebral Artery Origin Stenosis (VAOS).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Prospective RegistryAlso: ObservationalThis 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 | – |
Primary outcome
Incidence of recurrent stroke or death
Time frame: 1 Year post-treatment
Recurrent stroke of any type or death from any cause
1 secondary outcome
Incidence of Restenosis
Time frame: 1 Year post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Vertebral Artery Stenosis
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Drug-eluting Stenting Versus Medical Treatment for Extracranial Vertebral Artery Stenosis
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Rapamycin-Eluting Vertebral Stents In The Real-World Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
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Research on Early Prediction Model of Ischemic Cerebrovascular Disease Based on Artificial Intelligence Technology.
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Drug Eluting Stenting and Short Dual Antiplatelet Therapy for Preventing Recurrent Stroke in Vertebral Stenosis Registry Study
Vertebral Artery Stenosis
Recruiting
Efficacy of Drug-Eluting Vertebral Artery Stenting Treatment for Atherosclerotic Vertebral Arteries Stenosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Randall Edgell, MD principal investigator
St. Louis University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Artery Stenosis, run by St. Louis University at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Randall Edgell, MD (314-977-3129, randall.edgell@health.slu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of recurrent stroke or death (time frame: 1 Year post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.