NCT04042584

Brief Summary

Interventionnal Study to investigate the accuracy of our clinical based algorithm performed by using a visioconference device to assess the eligibility of acute recanalisation treatment (intraveinous thrombolysis (IVT) and/or mechanical thrombectomie (TM). Clinical identification of type of treatment is needed is pre-hospital triage of these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
215

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

November 20, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2021

Completed
Last Updated

May 20, 2026

Status Verified

March 1, 2022

Enrollment Period

2.1 years

First QC Date

July 31, 2019

Last Update Submit

May 19, 2026

Conditions

StrokeStroke, AcuteStroke, IschemicCerebrovascular Disorders

Keywords

StrokeMechanical thrombectomyTele-evaluationEmergency medical servicePre hospital

Outcome Measures

Primary Outcomes (1)

  • Final effective therapeutic decision

    Thrombolysis and/or thrombectomy : yes/no

    Day 0

Secondary Outcomes (3)

  • Therapeutic conviction

    Day 0

  • Remote evaluation failure

    Day 0

  • Theoretical therapeutic decision

    Day 0

Study Arms (1)

Visio conference device evaluation

EXPERIMENTAL

Neurological tele-evaluation by a neurologist

Procedure: Visio conference device evaluation (DVCM)

Interventions

Visio conference device evaluation (DVCM)PROCEDURE

Standard neurological tele-evaluation (limited to 15minutes) remotely carried out by a first neurologist via a tablet (DVCM) and an operator. A second neurologist assist at the assessment without intervention next to the patient. Once the remote assessment is complet, the second neurologist ensure the continuation of standard patient care.

Visio conference device evaluation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18
  • Suspicion of acute symptomatic stroke whose first symptoms are less than 24 hours old

You may not qualify if:

  • Stupor or coma requiring orotracheal intubation
  • Rankin pre stroke \> 4
  • Severe cognitive impairement
  • Contraindication to the realiszation of angiographic imaging
  • Participation refusal
  • Patient under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33 076, France

Location

MeSH Terms

Conditions

StrokeIschemic StrokeCerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 2, 2019

Study Start

November 20, 2019

Primary Completion

December 9, 2021

Study Completion

December 9, 2021

Last Updated

May 20, 2026

Record last verified: 2022-03

Locations

FR(1)