NCT03999983

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Nov 2019Dec 2026

First Submitted

Initial submission to the registry

June 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

November 19, 2019

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

6.3 years

First QC Date

June 25, 2019

Last Update Submit

February 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of recurrent stroke or death

    Recurrent stroke of any type or death from any cause

    1 Year post-treatment

Secondary Outcomes (1)

  • Incidence of Restenosis

    1 Year post-treatment

Interventions

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

Also known as: Observational

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Baptist Medical Center Jacksonville

Jacksonville, Florida, 32207, United States

RECRUITING

University of Southern Florida

Tampa, Florida, 33606, United States

RECRUITING

Northwestern Medicine Regional Medical Group

Winfield, Illinois, 60190, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

SSM DePaul Hospital

Bridgeton, Missouri, 63044, United States

RECRUITING

Saint Louis University

St Louis, Missouri, 63110, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Mercy Health Neuroscience Institute

Toledo, Ohio, 43608, United States

RECRUITING

Semmes Murphey Clinic

Memphis, Tennessee, 38120, United States

RECRUITING

Texas Tech University Health Science Center of El Paso

El Paso, Texas, 79905, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Vertebrobasilar Insufficiency

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Randall Edgell, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mollie Hoffmeyer, RN, BSN

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Neurology

Study Record Dates

First Submitted

June 25, 2019

First Posted

June 27, 2019

Study Start

November 19, 2019

Primary Completion

March 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations