StrokeOPTIC-AVCNCT04042584
Visio-conference for Pre-hospital Triage of Stroke Suspicions
A study testing Visio conference device evaluation (DVCM) in people with Stroke and Stroke, Acute, run by University Hospital, Bordeaux at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke, Acute, Stroke, Ischemic
- What is being tested?
- Visio conference device evaluation (DVCM)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2019to 9 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18
- Suspicion of acute symptomatic stroke whose first symptoms are less than 24 hours old
- Free Consent, informed writing signed by the participant or the person of confidence and the investigator (no later than the day of inclusion and before any examination required by research)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-hospital Optimization of Triage of Stroke Suspicions: Bringing an Embedded Visio Conference Device
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.
Read the detailed description
The outcome of ischemic stroke (IS) with large artery occlusion (LVO) is related to the volume of infarcted brain witch is related to the delay of arterial recanalisation. IVT is available in multiple stroke units in France but, in case of LVO, the association with TM is needed. The availability of endovascular capable centers is limited to tertiary care hospitals. As a result, pre-hospital identification of these patients is a priority and the optimization of the triage can be done by a clinical algorithm carried out by a neurological tele-evaluation.
OPTIC-AVC is a multi-phase study. This phase is about the evaluation of accuracy of our algorithm performed by a quick and standardized neurological tele-evaluation to predict the eligibility for recanalisation treatment (IVT and/or TM) of patients suspected of acute stroke in the emergency setting. The effective therapeutic decision for each patient, performed by another neurologist, will be blind to the theoretical therapeutic decision resulting from the algorithm.
Theoretical and effective therapeutic decision will be compared a posteriori
- Conditions
- Stroke, Stroke, Acute, Stroke, Ischemic, Cerebrovascular Disorders
- Being tested
- Visio conference device evaluation (DVCM)
- Keywords
- Stroke, Mechanical thrombectomy, Tele-evaluation, Emergency medical service, Pre hospital
- Medical subject headings
- Stroke, Ischemic Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visio conference device evaluation (DVCM)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Visio conference device evaluation | Experimental | Neurological tele-evaluation by a neurologist Receives: Procedure: Visio conference device evaluation (DVCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final effective therapeutic decision
Thrombolysis and/or thrombectomy : yes/no
Measured: Day 0
Secondary outcomes (3)
Therapeutic conviction
Theoretical conviction using Likert scales between the neurologist at the patient bedside and the neurologist using the device for tele-evaluation
Measured: Day 0
Remote evaluation failure
Remote evaluation failure rate
Measured: Day 0
Theoretical therapeutic decision
Theoretical therapeutic decision of the algorithm : thrombolysis and/or thrombectomy [yes/no]
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start20 Nov 2019
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042584
- Sponsor's protocol ID
- CHUBX 2017/42
- Other IDs
- 2018-A03123-52
- Acronym
- OPTIC-AVC
- Status last verified
- Mar 2022
- First submitted
- 31 Jul 2019
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lucas L, Georget A, Rouxel L, Briau P, Couture M, Liegey JS, Debruxelles S, Poli M, Sagnier S, Renou P, Olindo S, Rouanet F, Maurin X, Benard A, Sibon I. Remote neurological evaluation reliably identifies patients eligible to endovascular therapy while non-eligible to intravenous thrombolysis. Rev Neurol (Paris). 2024 Dec;180(10):1108-1116. doi: 10.1016/j.neurol.2024.05.006. Epub 2024 Jun 25.
PubMed 38918135
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-hospital Optimization of Triage of Stroke Suspicions: Bringing an Embedded Visio Conference Device
- ClinicalTrials.gov ID
- NCT04042584
- Acronym / sponsor ID
- OPTIC-AVC / CHUBX 2017/42
- Conditions
- Stroke, Stroke, Acute, Stroke, Ischemic, Cerebrovascular Disorders
- Keywords
- Stroke, Mechanical thrombectomy, Tele-evaluation, Emergency medical service, Pre hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The outcome of ischemic stroke (IS) with large artery occlusion (LVO) is related to the volume of infarcted brain witch is related to the delay of arterial recanalisation. IVT is available in multiple stroke units in France but, in case of LVO, the association with TM is needed. The availability of endovascular capable centers is limited to tertiary care hospitals. As a result, pre-hospital identification of these patients is a priority and the optimization of the triage can be done by a clinical algorithm carried out by a neurological tele-evaluation.
OPTIC-AVC is a multi-phase study. This phase is about the evaluation of accuracy of our algorithm performed by a quick and standardized neurological tele-evaluation to predict the eligibility for recanalisation treatment (IVT and/or TM) of patients suspected of acute stroke in the emergency setting. The effective therapeutic decision for each patient, performed by another neurologist, will be blind to the theoretical therapeutic decision resulting from the algorithm.
Theoretical and effective therapeutic decision will be compared a posteriori
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visio conference device evaluation | Experimental | Procedure: Visio conference device evaluation (DVCM)Neurological tele-evaluation by a neurologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18
- Suspicion of acute symptomatic stroke whose first symptoms are less than 24 hours old
- Free Consent, informed writing signed by the participant or the person of confidence and the investigator (no later than the day of inclusion and before any examination required by research)
Key exclusion criteria (6 listed)
- Stupor or coma requiring orotracheal intubation
- Rankin pre stroke > 4
- Severe cognitive impairement
- Contraindication to the realiszation of angiographic imaging
- Participation refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visio conference device evaluation (DVCM)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. | Procedure or surgery | Visio conference device evaluation |
Primary outcome
Final effective therapeutic decision
Time frame: Day 0
Thrombolysis and/or thrombectomy : yes/no
3 secondary outcomes
Therapeutic conviction
Time frame: Day 0
Remote evaluation failure
Time frame: Day 0
Theoretical therapeutic decision
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Results publication: PubMed 38918135Lucas L, Georget A, Rouxel L, Briau P, Couture M, Liegey JS, Debruxelles S, Poli M, Sagnier S, Renou P, Olindo S, Rouanet F, Maurin X, Benard A, Sibon I. Remote neurological evaluation reliably identifies patients eligible to endovascular therapy while non-eligible to intravenous thrombolysis. Rev Neurol (Paris). 2024 Dec;180(10):1108-1116. doi: 10.1016/j.neurol.2024.05.006. Epub 2024 Jun 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visio conference device evaluation (DVCM) in people with Stroke and Stroke, Acute, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final effective therapeutic decision (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04042584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.