Regional Strategy for Transfer for Mechanical Thrombectomy (START)

December 28, 2021 updated by: University Hospital, Montpellier

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Montpellier, France, 34295
        • Recruiting
        • Gui de Chauliac Hospital
        • Contact:
          • Caroline ARQUIZAN, MD
          • Phone Number: c-arquizan@chu-montpellier.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Acute cerebral infarct in the arterial circulation with large vessel occlusion

Description

Inclusion Criteria:

  1. Patient, admitted to the Emergency Department Head and Neck of the CHU de Montpellier, over 18 years old, without limit of upper age
  2. With TIA or cerebral infarction (confirmed by brain imaging (MRI or CT scan), acute (Time of stroke symptoms or discovery of patient ≤ 12 h)
  3. With anterior circulation intracranial large vessel occlusion (M1, T or proximal M2), confirmed by arterial imaging (magnetic resonance angiography-MRA- or angioscanner)
  4. No objection of the patient or their representative to being included in the cohort

Exclusion Criteria:

  1. Patient with severe intercurrent pathology impacting the short-term vital prognosis and making follow-up impossible
  2. Predictable impossibility of patient follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of mechanical thrombectomy treatment
Time Frame: 24 hours

Safety of medical complication

Complications of mechanical thrombectomy :

  • Vessel perforation
  • Intramural Arterial dissection
  • Symptomatic Intracerebral hemorrhage
  • embolization to a new territory
24 hours
Clinical evolution at 24 hours
Time Frame: 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
24 hours
Clinical evolution 7 days
Time Frame: 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
7 days
Proportion of patients having had mechanical trombectomy (and/or intravenous thrombolysis) amongst patient cohort.
Time Frame: 24 hours
Number of patients having had mechanical trombectomy (and/or intravenous thrombolysis) amongst patient cohort.
24 hours
Symptomatic Intracerebral Haemorrhage
Time Frame: 24 hours
symptomatic Intracerebral Haemorrhage on cerebral imaging at 24 hours
24 hours
Arterial Recanalisation with TICI score
Time Frame: post-act / 24 hours

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)
post-act / 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Caroline ARQUIZAN, MD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL17_0378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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