StrokeNCT06101004
A Multi-center, Non-interventional Prospective Clinical Trial to Evaluate the Safety and Effectiveness of CVA-FLOW
An observational study of Stroke, run by Cvaid Medical at 2 sites in 2 countries.
Trial summary
CVAid Medical Ltd. developed a smartphone-based tele stroke system named CVA-Flow. This system aims to evaluate the patient's neurological status, particularly detection of a possible stroke, assessment of stroke severity, and prediction of LVO as the cause of stroke. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- CVA-Flow
- Type of treatment
- Medical device
- How many people
- 460 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Oct 2023to 30 May 2024
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected acute stroke at the ED prior to treatment (tPA or EVT)
Who may be able to join
- Age ≥21 years of age
- With suspected acute stroke at the ED prior to treatment (tPA or EVT)
Who cannot join
- Patient intubated upon arrival
- Patient treated with tPA prior to arrival at the ED
- Patients with the following conditions:
- Brain tumors
- Hypoglycemia
- Toxic poisoning
Show all 12Show fewer
- Seizures
- Sepsis
- Subdural hematoma
- Encephalopathy (uremic, hepatic or other)
- Encephalitis
- Previous stroke with permanent neurological deficit
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Christopher Kellner, MD, 202-241-1547, christopher.kellner@mountsinai.org
About this study
Official title: A Multi-center, Non-interventional Prospective Clinical Trial to Evaluate the Safety and Effectiveness of CVA-FLOW Software Device for the Detection of Stroke and LVO in Patients With Suspected Stroke
CVAid Medical Ltd. developed a smartphone-based tele stroke system named CVA-Flow. This system aims to evaluate the patient's neurological status, particularly detection of a possible stroke, assessment of stroke severity, and prediction of LVO as the cause of stroke. The system's app guides the user through the examination step by step based on NIHSS/ Rapid Arterial Occlusion Evaluation (RACE) scales. The video can also be transferred offline to enable a distant stroke physician to assess the patient's status manually.
Read the detailed description
Management of acute ischemic stroke has changed dramatically following the evidence of the superiority of endovascular treatment (EVT) over best medical management, in the treatment of patients suffering large vessel occlusion (LVO), within 24 hours from onset of symptoms. The immediate consequence was an increase in the number of patients eligible for EVT, requiring secondary transfer of those patients from primary stroke centers to comprehensive stroke centers, capable of performing EVT.
EVT requires accurate and rapid diagnosis in the prehospital setting, as it is only indicated in specific patients with LVO, making up a small percentage of stroke cases, and its beneficial effects are highly time-dependent.
Of the existing diagnostic tools that accurately distinguish LVO cases from non-LVO ones, the National Institutes of Health Stroke Scale (NIHSS) is the most recommended tool by healthcare providers to objectively quantify the neurological impairment caused by a suspected stroke. Nevertheless, the NIHSS is not considered to be feasible in the pre-hospital setting of EMS, since it requires a greater degree of training, is thought to be too time-consuming, and has not been as well validated in the prehospital setting.
Several previous studies showed feasibility and reliability of the use of telemedicine for determining the NIHSS score from afar in stroke patients in real time, in simulated stroke patients in real time and captured video segments. Previous studies did not use designated applications designed for performing neurological evaluations, relying on simple applications for video conferencing instead, therefore requiring applicators to possess knowledge in performing neurological examinations and evaluators to be online the whole examination time.
To resolve this issue, CVAid Medical Ltd. developed a smartphone-based tele stroke system named CVA-Flow. This system aims to evaluate the patient's neurological status, particularly detection of a possible stroke, assessment of stroke severity, and prediction of LVO as the cause of stroke. The system's app guides the user through the examination step by step based on NIHSS/ Rapid Arterial Occlusion Evaluation (RACE) scales. The video can also be transferred offline to enable a distant stroke physician to assess the patient's status manually.
- Conditions
- Stroke
- Being tested
- CVA-Flow
- Keywords
- emergency department, LVO
- Medical subject headings
- Stroke, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVA-FlowDevice
CVA-FLOW Software Device is indicated for the detection of Stroke and LVO in patients with suspected stroke.
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-primary endpoints are defined to demonstrate the performance of CVA-Flow to detect patients with stroke among all suspected patients.
The co-primary endpoints are defined as follows,
Reference for each case shall be scored by the reviewer neurologist dichotomously as:
- Positive - at least one relevant finding, or;
- Negative - no relevant findings.
Each case shall also be scored dichotomously by CVA-Flow software as:
- Positive - suspected stroke, or;
- Negative - no suspected stroke.
Measured: From the time of recruitment of the subject to discharge from hospital estimated to be up to 4 weeks
Secondary outcomes (1)
Confirmatory secondary endpoints are defined to demonstrate the performance of CVA-Flow to detect patients with LVO stroke among all suspected patients without head bleeding.
The confirmatory secondary endpoints are defined similarly to the co-primary endpoints as follows,
Reference for each case shall be scored by the reviewer radiologist dichotomously as:
- Positive - at least one relevant finding (LVO), or;
- Negative - no relevant findings.
Each case shall also be scored dichotomously by CVA-Flow software as:
- Positive - suspected LVO, or;
- Negative - no suspected relevant findings.
Measured: From the time of recruitment of the subject to discharge from hospital estimated to be up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start23 Oct 2023 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cvaid Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101004
- Sponsor's protocol ID
- CVA-001
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Non-interventional Prospective Clinical Trial to Evaluate the Safety and Effectiveness of CVA-FLOW Software Device for the Detection of Stroke and LVO in Patients With Suspected Stroke
- ClinicalTrials.gov ID
- NCT06101004
- Acronym / sponsor ID
- CVA-001
- Conditions
- Stroke
- Keywords
- emergency department, LVO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Cvaid MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Study start
- 23 Oct 2023 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 25 Oct 2023 (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.
CVAid Medical Ltd. developed a smartphone-based tele stroke system named CVA-Flow. This system aims to evaluate the patient's neurological status, particularly detection of a possible stroke, assessment of stroke severity, and prediction of LVO as the cause of stroke. The system's app guides the user through the examination step by step based on NIHSS/ Rapid Arterial Occlusion Evaluation (RACE) scales. The video can also be transferred offline to enable a distant stroke physician to assess the patient's status manually.
Detailed description
Management of acute ischemic stroke has changed dramatically following the evidence of the superiority of endovascular treatment (EVT) over best medical management, in the treatment of patients suffering large vessel occlusion (LVO), within 24 hours from onset of symptoms. The immediate consequence was an increase in the number of patients eligible for EVT, requiring secondary transfer of those patients from primary stroke centers to comprehensive stroke centers, capable of performing EVT.
EVT requires accurate and rapid diagnosis in the prehospital setting, as it is only indicated in specific patients with LVO, making up a small percentage of stroke cases, and its beneficial effects are highly time-dependent.
Of the existing diagnostic tools that accurately distinguish LVO cases from non-LVO ones, the National Institutes of Health Stroke Scale (NIHSS) is the most recommended tool by healthcare providers to objectively quantify the neurological impairment caused by a suspected stroke. Nevertheless, the NIHSS is not considered to be feasible in the pre-hospital setting of EMS, since it requires a greater degree of training, is thought to be too time-consuming, and has not been as well validated in the prehospital setting.
Several previous studies showed feasibility and reliability of the use of telemedicine for determining the NIHSS score from afar in stroke patients in real time, in simulated stroke patients in real time and captured video segments. Previous studies did not use designated applications designed for performing neurological evaluations, relying on simple applications for video conferencing instead, therefore requiring applicators to possess knowledge in performing neurological examinations and evaluators to be online the whole examination time.
To resolve this issue, CVAid Medical Ltd. developed a smartphone-based tele stroke system named CVA-Flow. This system aims to evaluate the patient's neurological status, particularly detection of a possible stroke, assessment of stroke severity, and prediction of LVO as the cause of stroke. The system's app guides the user through the examination step by step based on NIHSS/ Rapid Arterial Occlusion Evaluation (RACE) scales. The video can also be transferred offline to enable a distant stroke physician to assess the patient's status manually.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected acute stroke at the ED prior to treatment (tPA or EVT)
Key inclusion criteria (2 listed)
- Age ≥21 years of age
- With suspected acute stroke at the ED prior to treatment (tPA or EVT)
Key exclusion criteria (12 listed)
- Patient intubated upon arrival
- Patient treated with tPA prior to arrival at the ED
- Patients with the following conditions:
- Previous stroke with permanent neurological deficit
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 |
|---|---|---|
| CVA-FlowCVA-FLOW Software Device is indicated for the detection of Stroke and LVO in patients with suspected stroke. | Device | – |
Primary outcome
Co-primary endpoints are defined to demonstrate the performance of CVA-Flow to detect patients with stroke among all suspected patients.
Time frame: From the time of recruitment of the subject to discharge from hospital estimated to be up to 4 weeks
The co-primary endpoints are defined as follows, Reference for each case shall be scored by the reviewer neurologist dichotomously as: * Positive - at least one relevant finding, or; * Negative - no relevant findings. Each case shall also be scored dichotomously by CVA-Flow software as: * Positive - suspected stroke, or; * Negative - no suspected stroke.
1 secondary outcome
Confirmatory secondary endpoints are defined to demonstrate the performance of CVA-Flow to detect patients with LVO stroke among all suspected patients without head bleeding.
Time frame: From the time of recruitment of the subject to discharge from hospital estimated to be up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Cvaid Medical at 2 sites in 2 countries.
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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia Dickman, PhD (+972-54-5595951, dalia@cvaidmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-primary endpoints are defined to demonstrate the performance of CVA-Flow to detect patients with stroke among all suspected patients. (time frame: From the time of recruitment of the subject to discharge from hospital estimated to be up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2023.