Registry for treating vertebral artery stenosis to prevent stroke
Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)
St. Louis University · NCT03999983
This study collects information from patients who have had strokes caused by narrowed vertebral arteries to see if treatments like stenting and medication can help prevent more strokes over 18 months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | St. Louis University (other) |
| Locations | 10 sites (Jacksonville, Florida and 9 other locations) |
| Trial ID | NCT03999983 on ClinicalTrials.gov |
What this trial studies
This study is a registry that collects data on patients who have experienced strokes due to vertebral artery origin stenosis (VAOS). It includes both retrospective and prospective data on patients treated with stenting and medical management. The aim is to evaluate clinical outcomes over an 18-month period following treatment. The registry focuses on understanding the effectiveness of these interventions in preventing recurrent strokes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 who have had a posterior circulation ischemic event and confirmed significant stenosis in the vertebral artery.
Not a fit: Patients who are pregnant, have contraindications to anti-platelet drugs, or have severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into effective treatments for preventing recurrent strokes in patients with vertebral artery stenosis.
How similar studies have performed: Other studies have explored similar interventions for vertebral artery stenosis, but the specific registry approach may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jacksonville, Florida and 9 other locations
- Baptist Medical Center Jacksonville — Jacksonville, Florida, United States (RECRUITING)
- University of Southern Florida — Tampa, Florida, United States (RECRUITING)
- Northwestern Medicine Regional Medical Group — Winfield, Illinois, United States (RECRUITING)
- University of Iowa — Iowa City, Iowa, United States (RECRUITING)
- SSM DePaul Hospital — Bridgeton, Missouri, United States (RECRUITING)
- Saint Louis University — St Louis, Missouri, United States (RECRUITING)
- Cleveland Clinic — Cleveland, Ohio, United States (NOT_YET_RECRUITING)
- Mercy Health Neuroscience Institute — Toledo, Ohio, United States (RECRUITING)
- Semmes Murphey Clinic — Memphis, Tennessee, United States (RECRUITING)
- Texas Tech University Health Science Center of El Paso — El Paso, Texas, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Randall Edgell, MD — St. Louis University
- Study coordinator: Randall Edgell, MD
- Email: randall.edgell@health.slu.edu
- Phone: 314-977-3129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vertebral Artery Stenosis