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Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)

NCT03999983 — Recruiting, 150 participants, St. Louis University

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RegistryNCT03999983, acronym VOTER
StatusRecruiting
Study typeObservational
Enrollment150 (Estimated)
SponsorSt. Louis University (Other)
ConditionsVertebral Artery Stenosis
InterventionsObservational Prospective Registry (Other)
Datesstart 2019-11-19, primary completion 2026-03-01 (estimated), completion 2026-12-01 (estimated), first posted 2019-06-27, last updated 2025-02-12
Locations10 sites in United States

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-Summary

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

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+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.

+Arms and interventions

  • Observational Prospective Registry (Other), also known as 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

+Outcome measures

Primary outcomes

  • Incidence of recurrent stroke or death [1 Year post-treatment]: Recurrent stroke of any type or death from any cause

Secondary outcomes

  • Incidence of Restenosis [1 Year post-treatment]: Restenosis in VAOS patients treated with drug-eluting stents.

+Eligibility

Sex: All, ages: 18 Years to 90 Years

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

+Locations (10)

FacilityCityCountryStatus
Baptist Medical Center JacksonvilleJacksonville, FloridaUnited StatesRecruiting
University of Southern FloridaTampa, FloridaUnited StatesRecruiting
Northwestern Medicine Regional Medical GroupWinfield, IllinoisUnited StatesRecruiting
University of IowaIowa City, IowaUnited StatesRecruiting
SSM DePaul HospitalBridgeton, MissouriUnited StatesRecruiting
Saint Louis UniversitySt Louis, MissouriUnited StatesRecruiting
Cleveland ClinicCleveland, OhioUnited StatesNot yet recruiting
Mercy Health Neuroscience InstituteToledo, OhioUnited StatesRecruiting
Semmes Murphey ClinicMemphis, TennesseeUnited StatesRecruiting
Texas Tech University Health Science Center of El PasoEl Paso, TexasUnited StatesNot yet recruiting

+Investigators

My Notes