Regional Strategy for Transfer for Mechanical Thrombectomy | NCT04046757

Studies
Regional Strategy for Transfer for Mechanical Thrombectomy

NCT04046757

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

Dec 29, 2021Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Stroke
Ischemic
Large Vessel Occlusion

Interventions

Mechanical thrombectomy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2019Actual

Primary Completion Date

Jun 2022Estimated

Completion Date

Jun 2022Estimated

First Submitted Date

Jun 7, 2019

First Submission Date that Met QC Criteria

Aug 2, 2019

First Posted Date

Aug 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2021

Last Update Posted Date

Dec 29, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mechanical thrombectomy	Other	Neuroradiological endovascular treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	3 months

Secondary Outcomes

Measure	Description	Time Frame
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	24 hours
Clinical evolution at 24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Acute cerebral infarct in the arterial circulation with large vessel occlusion

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Caroline ARQUIZAN, MD	Contact	4 67 33 72 33		c-arquizan@chu-montpellier.fr
Jessica HATTINGUAIS, CRA	Contact	4 67 33 56 53	+33	j-hattinguais@chu-montpellier.fr

Overall Officials

Name	Affiliation	Role
Caroline ARQUIZAN, MD	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gui De Chauliac Hospital	Recruiting	Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D007511	Ischemia
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided