Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)

Vertebral Artery Stenosis Clinical Trial

— VOTER  

Official title:

Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03999983
• Other study ID #: 29760
• Status: Active, not recruiting
• Start date: November 19, 2019
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Vertebral Artery Stenosis
• Vertebrobasilar Insufficiency

Intervention

Other:
• Observational Prospective Registry
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

Locations

Country	Name	City	State
United States	SSM DePaul Hospital	Bridgeton	Missouri
United States	Cleveland Clinic	Cleveland	Ohio
United States	Texas Tech University Health Science Center of El Paso	El Paso	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Baptist Medical Center Jacksonville	Jacksonville	Florida
United States	Semmes Murphey Clinic	Memphis	Tennessee
United States	Saint Louis University	Saint Louis	Missouri
United States	University of Southern Florida	Tampa	Florida
United States	Mercy Health Neuroscience Institute	Toledo	Ohio
United States	Northwestern Medicine Regional Medical Group	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of recurrent stroke or death	Recurrent stroke of any type or death from any cause	1 Year post-treatment
Secondary	Incidence of Restenosis	Restenosis in VAOS patients treated with drug-eluting stents.	1 Year post-treatment