Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)

Recruiting

• Conditions: Vertebral Artery Stenosis

• Registration Number: NCT03999983
• Lead Sponsor: St. Louis University

Brief Summary

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 Timeline

• Study First Submitted: 2019-06-25
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-27
• Study Start: 2019-11-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-03
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of recurrent stroke or death	1 Year post-treatment	Recurrent stroke of any type or death from any cause

Secondary Outcome Measures

Name	Time	Method
Incidence of Restenosis	1 Year post-treatment	Restenosis in VAOS patients treated with drug-eluting stents.

Trial Locations

Locations (10)

Baptist Medical Center Jacksonville; 🇺🇸 Jacksonville, Florida, United States

University of Southern Florida; 🇺🇸 Tampa, Florida, United States

Northwestern Medicine Regional Medical Group; 🇺🇸 Winfield, Illinois, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

SSM DePaul Hospital; 🇺🇸 Bridgeton, Missouri, United States

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Mercy Health Neuroscience Institute; 🇺🇸 Toledo, Ohio, United States

Semmes Murphey Clinic; 🇺🇸 Memphis, Tennessee, United States

Texas Tech University Health Science Center of El Paso; 🇺🇸 El Paso, Texas, United States