StrokeSTARTNCT04046757
Regional Strategy for Transfer for Mechanical Thrombectomy
An observational study of Stroke and Ischemic, run by University Hospital, Montpellier at 1 site in France.
Trial summary
A mono-centre observational study with the aim of compare clinical outcome at 3 month on patients admitted with recent cerebral infarct and intracranial large vessel occlusion in the anterior circulation who are eligible for mechanical thrombectomy in three different position : Patients admitted first in the… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke, Ischemic, Large Vessel Occlusion
- What is being tested?
- Mechanical thrombectomy
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to Jun 2022
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute cerebral infarct in the arterial circulation with large vessel occlusion
Who may be able to join
- Patient, admitted to the Emergency Department Head and Neck of the CHU de Montpellier, over 18 years old, without limit of upper age
- With TIA or cerebral infarction (confirmed by brain imaging (MRI or CT scan), acute (Time of stroke symptoms or discovery of patient ≤ 12 h)
- With anterior circulation intracranial large vessel occlusion (M1, T or proximal M2), confirmed by arterial imaging (magnetic resonance angiography-MRA- or angioscanner)
- No objection of the patient or their representative to being included in the cohort
Who cannot join
- Patient with severe intercurrent pathology impacting the short-term vital prognosis and making follow-up impossible
- Predictable impossibility of patient follow-up
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Gui De Chauliac Hospital
Montpellier, 34295
Caroline ARQUIZAN, MD, c-arquizan@chu-montpellier.fr
About this study
Official title: Strategy for Transfer to Emergency Head And Neck (UTEC) of Stroke Alerts With Suspicion of Large Vessel Occlusion for Mechanical Thrombectomy in the Languedoc Roussillon Region
A mono-centre observational study with the aim of compare clinical outcome at 3 month on patients admitted with recent cerebral infarct and intracranial large vessel occlusion in the anterior circulation who are eligible for mechanical thrombectomy in three different position : Patients admitted first in the Comprehensive Stroke Center of Montpellier, those transferred after Proximity Stroke Unit or prehospital bypass for patients with high suspicion of large vessel occlusion.to the Comprehensive Stroke Center of Montpellier
Read the detailed description
Multiple RCT has recently proved the superiority of mechanical thrombectomy compared to the best medical therapy (BMT) on patients with recent cerebral infarct and anterior circulation intracranial large vessel occlusion.
In the Occitanie-Est region (ex Languedoc Roussillon), comprising 6 Stroke Unit, only the Comprehensive Stroke Unit of the CHU de Montpellier has a centre of interventional neuroradiology (NRI) that can perform mechanical thrombectomy.
Patients suspected of stroke are referred to the nearest SU, then the candidates for thrombectomy, are transferred secondarily to the Stroke Center in Montpellier.
Currently, there is no evidence that an initial management in a proximity stroke unit and a secondary transfer for a mechanical thrombectomy is associated with a loss of chance for patients, compared to patients initially treated at the Stroke Center regional reference.
The objective of the study is to compare clinical outcome on patients admitted first in the Comprehensive Stroke Center of Montpellier those transferred after Proximity Stroke Unit or directly admitted when high suspicion of large vessel occlusion.
- Conditions
- Stroke, Ischemic, Large Vessel Occlusion
- Being tested
- Mechanical thrombectomy
- Keywords
- Ischemic stroke, Mechanical Thrombectomy
- Medical subject headings
- Stroke, Ischemia, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical thrombectomyOther
Neuroradiological endovascular treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Score (mRS)
Good functional outcome ( defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset Modified Rankin scale . Range 0 (asymptomatic) to 6 (death)
- Good outcome : 0 to 2
- Disability : 3 to 5
- Bad outcome : 5 and 6
Measured: 3 months
Secondary outcomes (6)
Incidence of mechanical thrombectomy treatment
Safety of medical complication
Complications of mechanical thrombectomy :
- Vessel perforation
- Intramural Arterial dissection
- Symptomatic Intracerebral hemorrhage
- embolization to a new territory
Measured: 24 hours
Clinical evolution at 24 hours
NIHSS scale and NIHSS scale variation between the inclusion at 24 hours
National Institutes of Health Stroke Scale (NIHSS). Range 0-42. Neurological severity score at the acute phase :
- Minor stroke : 0 to 5
- Moderate stroke 6 to 20
- Severe stroke up to 21
Measured: 24 hours
Clinical evolution 7 days
NIHSS scale and NIHSS scale variation between the inclusion at 7 days
National Institutes of Health Stroke Scale (NIHSS). Range 0-42. Neurological severity score at the acute phase :
- Minor stroke : 0 to 5
- Moderate stroke 6 to 20
- Severe stroke up to 21
Measured: 7 days
Proportion of patients having had mechanical trombectomy (and/or intravenous thrombolysis) amongst patient cohort.
Number of patients having had mechanical trombectomy (and/or intravenous thrombolysis) amongst patient cohort.
Measured: 24 hours
Symptomatic Intracerebral Haemorrhage
symptomatic Intracerebral Haemorrhage on cerebral imaging at 24 hours
Measured: 24 hours
Arterial Recanalisation with TICI score
Quality of revascularization after mechanical thrombectomy : immediate post-Mechanical-Trombectomy evaluation for patient having had mechanical thrombectomy and at 24 hours for all patient cohort.
TICI score (Thrombolysis In Cerebral Infarction grading system) describe the quality of revascularization after mechanical thrombectomy (Grade 0 for no perfusion at 3 for Complete perfusion)
Measured: post-act / 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 Oct 2019
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline ARQUIZAN, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046757
- Sponsor's protocol ID
- RECHMPL17_0378
- Acronym
- START
- Status last verified
- Dec 2021
- First submitted
- 7 Jun 2019
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy for Transfer to Emergency Head And Neck (UTEC) of Stroke Alerts With Suspicion of Large Vessel Occlusion for Mechanical Thrombectomy in the Languedoc Roussillon Region
- ClinicalTrials.gov ID
- NCT04046757
- Acronym / sponsor ID
- START / RECHMPL17_0378
- Conditions
- Stroke, Ischemic, Large Vessel Occlusion
- Keywords
- Ischemic stroke, Mechanical Thrombectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 6 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.
A mono-centre observational study with the aim of compare clinical outcome at 3 month on patients admitted with recent cerebral infarct and intracranial large vessel occlusion in the anterior circulation who are eligible for mechanical thrombectomy in three different position : Patients admitted first in the Comprehensive Stroke Center of Montpellier, those transferred after Proximity Stroke Unit or prehospital bypass for patients with high suspicion of large vessel occlusion.to the Comprehensive Stroke Center of Montpellier
Detailed description
Multiple RCT has recently proved the superiority of mechanical thrombectomy compared to the best medical therapy (BMT) on patients with recent cerebral infarct and anterior circulation intracranial large vessel occlusion.
In the Occitanie-Est region (ex Languedoc Roussillon), comprising 6 Stroke Unit, only the Comprehensive Stroke Unit of the CHU de Montpellier has a centre of interventional neuroradiology (NRI) that can perform mechanical thrombectomy.
Patients suspected of stroke are referred to the nearest SU, then the candidates for thrombectomy, are transferred secondarily to the Stroke Center in Montpellier.
Currently, there is no evidence that an initial management in a proximity stroke unit and a secondary transfer for a mechanical thrombectomy is associated with a loss of chance for patients, compared to patients initially treated at the Stroke Center regional reference.
The objective of the study is to compare clinical outcome on patients admitted first in the Comprehensive Stroke Center of Montpellier those transferred after Proximity Stroke Unit or directly admitted when high suspicion of large vessel occlusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute cerebral infarct in the arterial circulation with large vessel occlusion
Key inclusion criteria (4 listed)
- Patient, admitted to the Emergency Department Head and Neck of the CHU de Montpellier, over 18 years old, without limit of upper age
- With TIA or cerebral infarction (confirmed by brain imaging (MRI or CT scan), acute (Time of stroke symptoms or discovery of patient ≤ 12 h)
- With anterior circulation intracranial large vessel occlusion (M1, T or proximal M2), confirmed by arterial imaging (magnetic resonance angiography-MRA- or angioscanner)
- No objection of the patient or their representative to being included in the cohort
Key exclusion criteria (2 listed)
- Patient with severe intercurrent pathology impacting the short-term vital prognosis and making follow-up impossible
- Predictable impossibility of patient follow-up
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 |
|---|---|---|
| Mechanical thrombectomyNeuroradiological endovascular treatment | Other | – |
Primary outcome
Modified Rankin Score (mRS)
Time frame: 3 months
Good functional outcome ( defined by a Modified Rankin Scale of 0-2, 3 months after stroke onset Modified Rankin scale . Range 0 (asymptomatic) to 6 (death) * Good outcome : 0 to 2 * Disability : 3 to 5 * Bad outcome : 5 and 6
6 secondary outcomes
Incidence of mechanical thrombectomy treatment
Time frame: 24 hours
Clinical evolution at 24 hours
Time frame: 24 hours
Clinical evolution 7 days
Time frame: 7 days
Proportion of patients having had mechanical trombectomy (and/or intravenous thrombolysis) amongst patient cohort.
Time frame: 24 hours
Symptomatic Intracerebral Haemorrhage
Time frame: 24 hours
Arterial Recanalisation with TICI score
Time frame: post-act / 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
Caroline ARQUIZAN, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Ischemic, run by University Hospital, Montpellier 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 4 inclusion and 2 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 29 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline ARQUIZAN, MD (4 67 33 72 33, c-arquizan@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Score (mRS) (time frame: 3 months). 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 29 Dec 2021.