Vertebral Artery Origin Treatment Via Endovascular Techni... | NCT03999983

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 19, 2019Actual

Primary Completion Date

Mar 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Jun 25, 2019

First Submission Date that Met QC Criteria

Jun 25, 2019

First Posted Date

Jun 27, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2025

Last Update Posted Date

Feb 12, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Randall C. Edgell, MD, FSVIN, Professor, Department of Neurology, St. Louis UniversityPrincipal Investigator

Lead Sponsor

St. Louis UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational Prospective Registry	Other	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		Observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of recurrent stroke or death	Recurrent stroke of any type or death from any cause	1 Year post-treatment

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Restenosis	Restenosis in VAOS patients treated with drug-eluting stents.	1 Year post-treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients admitted for stroke and evidence of Vertebral Artery Origin Stenosis (VAOS).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Randall Edgell, MD	Contact	314-977-3129		randall.edgell@health.slu.edu
Mollie Hoffmeyer, RN, BSN	Contact	314-617-3313		mollie.hoffmeyer@health.slu.edu

Overall Officials

Name	Affiliation	Role
Randall Edgell, MD	St. Louis University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baptist Medical Center Jacksonville	Recruiting	Jacksonville	Florida	32207	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration