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Large Artery Occlusion Treated in Extended Time With Mechanical Thrombectomy Trial (LATE-MT)

Primary Purpose

Acute Ischemic Stroke

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Mechanical thrombectomy

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Acute ischemic stroke, Large vessel occlusion, Mechanical thrombectomy, Extended time, Randomised clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥18 years
Present 24-72 hours of stroke onset or last seen well
Clinical diagnosis of AIS due to anterior circulation LVO (from internal carotid artery (ICA) extracranial segment to middle cerebral artery (MCA) M1 and M2 segment) on brain imaging
National Institute of Health stroke scale (NIHSS) ≥6 at randomisation
Viable cerebral tissue on computerized tomography perfusion (CTP) or magnetic resonance imaging perfusion (MRP) assessed: infarct core volume <50mL, mismatch ratio ≥1.8 and mismatch volume ≥15mL
Written informed consent (by patient or proxy, according to local requirements)

Exclusion Criteria:

Clinical Exclusion Criteria

Considered unlikely to benefit from trial (e.g. advanced dementia, major pre-stroke disability (prior modified Rankins scale (mRS) ≥2), high likelihood of early death), as judged by the responsible treating clinician
Major co-morbid disease that could interfere with outcome assessments and follow-up (e.g. cancer, severe heart failure, kidney failure)
Pregnancy
Unable to undergo a CTP or MRP
Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure
Seizures at stroke onset or before randomization and baseline NIHSS scores cannot be accurately determined
Baseline blood glucose of <50mg/dL (2.78 mmol/L) or >400mg/dL (22.20 mmol/L)
Baseline platelet count <50,000/uL
Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with International normalized ratio (INR) >3
Severe, sustained hypertension (systolic blood pressure (BP) >220 mmHg or diastolic BP >120 mmHg)
Presumed septic embolus, suspicion of bacterial endocarditis
EVT attempted after stroke onset
Unlikely to participate in follow-up assessments
Currently participating in another trial that may affect outcomes.
Any other condition that, in the opinion of the investigator will pose a significant hazard to the subject if participating in the trial.

Neuroimaging Exclusion Criteria

Intracranial hemorrhage (ICH), including parenchymal hemorrhage, ventricular hemorrhage, subarachnoid hemorrhage, and subdural/exsanguination
Evidence of intracranial tumor (except small meningioma)
Significant mass effect with midline shift
Aortic dissection
Intracranial stent implanted in the same vascular territory
Any other condition that may affect EVT procedure, like the tortuous vascular path the device is difficult to reach the target position or difficult to recover
Occlusions in multiple vascular territories confirmed on Computerized tomography angiography (CTA)/ Magnetic resonance imaging angiography (MRA) (e.g. bilateral MCA occlusions, or an MCA and a basilar artery occlusion)

Sites / Locations

Changhai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Mechanical thrombectomy to be initiated as soon as possible after randomisation.

Patients assigned to the control group will avoid treating MT and only receive the standard medical treatment according to local guidelines.

Outcomes

Primary Outcome Measures

Functional recovery (level of disability)

Shift (improvement) in scores on the modified Rankin scale (mRS). The value range 0-6: higher scores mean a worse outcome.

Secondary Outcome Measures

Neurological impairment

Measured by scores on the National Institute of Health Stroke Scale (NIHSS). The value range 0-42: higher scores mean a worse outcome.

Death or major disability

modified Rankin scale (mRS) 3-6

Separately on death and disability

modified Rankin scale (mRS) 3-5

Health-related Quality of Life (HRQoL)

using EQ-5D. European Quality of Life 5-dimensional questionnaire. The EQ-5D comprises five dimensions of health: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, and anxiety and depression. . EQ-5D-5L, includes five levels of severity for each dimension (no problems, slight problems, moderate problems, severe problems, and extreme problems). The value range 0-100: Higher scores mean a worse outcome.

Utility-weighted modified Rankin scale scores

Utility-weighted modified Rankin scale scores. The value range from 0 to 10: higher scores mean a better outcome. Higher scores mean a worse outcome.

Duration of hospitalization

Days of hospitalization

Residence

Days of residence

Hospital service costs

Health economic measurement

Infarct volume on DWI, or CT

Infarct volume on DWI, or CT if DWI not feasible

Recanalization

Recanalization confirmed on imaging

Full Information

NCT ID

NCT05326932

First Posted

March 29, 2022

Last Updated

February 28, 2023

Sponsor

The George Institute for Global Health, China

Collaborators

Changhai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05326932

Brief Title

Large Artery Occlusion Treated in Extended Time With Mechanical Thrombectomy Trial

Acronym

LATE-MT

Official Title

An Investigator Initiated and Conducted, Prospective, Multicenter, Randomized Outcome-blinded Study of Treating Mechanical Thrombectomy Exceeding 24 Hours in Patients With Acute Ischemic Stroke Due to Large Vessel Occlusion

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 3, 2022 (Actual)

Primary Completion Date

October 30, 2024 (Anticipated)

Study Completion Date

January 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The George Institute for Global Health, China

Collaborators

Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A multi-center, prospective, randomized, open-label, adaptive group sequential designed, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS

Detailed Description

The LATE-MT trial aims to determine that compared with standard medical care without MT, performing MT in a time window that exceeds 24 hours after last seen well, is superior on the functional outcome in AIS patients due to LVO who have been carefully selected by clinical and imaging criteria. The secondary aims include comparing with standard medical care without MT, to determine whether performing MT exceeding 24 hours of last known well is safe on the risks of any ICH, sICH, and any SAE. Other secondary aims include early improvement in neurological recovery as measured by NIHSS scores at 7 days; successful recanalization rate; imaging measurements of infarct size at 24-48 hours; death or major disability (mRS 3-6); separately on death and disability (mRS 3-5); HRQoL using Euro-QoL EQ-5D questionnaire; utility-weighted modified Rankin scale scores; duration of hospitalization; residence; and hospital service costs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke

Keywords

Acute ischemic stroke, Large vessel occlusion, Mechanical thrombectomy, Extended time, Randomised clinical trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

382 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

Mechanical thrombectomy to be initiated as soon as possible after randomisation.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Patients assigned to the control group will avoid treating MT and only receive the standard medical treatment according to local guidelines.

Intervention Type

Procedure

Intervention Name(s)

Mechanical thrombectomy

Intervention Description

Subjects in intervention group will receive MT as soon as possible. Investigators and clinicians should strive to reduce delays of pre-surgery procedure and follow the local standard guideline of MT during the operation and perioperative period. All CFDA approved devices are allowed in this trial. Angioplasty and stent placement can be performed at the discretion of the physicians. Base on site experience, the randomization-operation start period should be within 60 minutes.

Primary Outcome Measure Information:

Title

Functional recovery (level of disability)

Description

Shift (improvement) in scores on the modified Rankin scale (mRS). The value range 0-6: higher scores mean a worse outcome.

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Neurological impairment

Description

Measured by scores on the National Institute of Health Stroke Scale (NIHSS). The value range 0-42: higher scores mean a worse outcome.

Time Frame

24 hours and 7 days

Title

Death or major disability

Description

modified Rankin scale (mRS) 3-6

Time Frame

90 days

Title

Separately on death and disability

Description

modified Rankin scale (mRS) 3-5

Time Frame

90 days

Title

Health-related Quality of Life (HRQoL)

Description

Time Frame

90 days

Title

Utility-weighted modified Rankin scale scores

Description

Utility-weighted modified Rankin scale scores. The value range from 0 to 10: higher scores mean a better outcome. Higher scores mean a worse outcome.

Time Frame

90 days

Title

Duration of hospitalization

Description

Days of hospitalization

Time Frame

90 days

Title

Residence

Description

Days of residence

Time Frame

90 days

Title

Hospital service costs

Description

Health economic measurement

Time Frame

90 days

Title

Infarct volume on DWI, or CT

Description

Infarct volume on DWI, or CT if DWI not feasible

Time Frame

24 hours

Title

Recanalization

Description

Recanalization confirmed on imaging

Time Frame

24 hours after MT

Other Pre-specified Outcome Measures:

Title

Intracerebral hemorrhage (ICH)

Description

a) symptomatic ICH, based on previous criteria; b) ICH of any type in brain imaging

Time Frame

24 hours and 90 days

Title

Death

Description

Death

Time Frame

7 days and 90 days

Title

Serious adverse events (SAE)

Description

All SAE during follow-up in all randomized patients

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 years Present 24-72 hours of stroke onset or last seen well Clinical diagnosis of AIS due to anterior circulation LVO (from internal carotid artery (ICA) extracranial segment to middle cerebral artery (MCA) M1 and M2 segment) on brain imaging National Institute of Health stroke scale (NIHSS) ≥6 at randomisation Viable cerebral tissue on computerized tomography perfusion (CTP) or magnetic resonance imaging perfusion (MRP) assessed: infarct core volume <50mL, mismatch ratio ≥1.8 and mismatch volume ≥15mL Written informed consent (by patient or proxy, according to local requirements) Exclusion Criteria: Clinical Exclusion Criteria Considered unlikely to benefit from trial (e.g. advanced dementia, major pre-stroke disability (prior modified Rankins scale (mRS) ≥2), high likelihood of early death), as judged by the responsible treating clinician Major co-morbid disease that could interfere with outcome assessments and follow-up (e.g. cancer, severe heart failure, kidney failure) Pregnancy Unable to undergo a CTP or MRP Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure Seizures at stroke onset or before randomization and baseline NIHSS scores cannot be accurately determined Baseline blood glucose of <50mg/dL (2.78 mmol/L) or >400mg/dL (22.20 mmol/L) Baseline platelet count <50,000/uL Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with International normalized ratio (INR) >3 Severe, sustained hypertension (systolic blood pressure (BP) >220 mmHg or diastolic BP >120 mmHg) Presumed septic embolus, suspicion of bacterial endocarditis EVT attempted after stroke onset Unlikely to participate in follow-up assessments Currently participating in another trial that may affect outcomes. Any other condition that, in the opinion of the investigator will pose a significant hazard to the subject if participating in the trial. Neuroimaging Exclusion Criteria Intracranial hemorrhage (ICH), including parenchymal hemorrhage, ventricular hemorrhage, subarachnoid hemorrhage, and subdural/exsanguination Evidence of intracranial tumor (except small meningioma) Significant mass effect with midline shift Aortic dissection Intracranial stent implanted in the same vascular territory Any other condition that may affect EVT procedure, like the tortuous vascular path the device is difficult to reach the target position or difficult to recover Occlusions in multiple vascular territories confirmed on Computerized tomography angiography (CTA)/ Magnetic resonance imaging angiography (MRA) (e.g. bilateral MCA occlusions, or an MCA and a basilar artery occlusion)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lily Song, PhD

Phone

+86 13916466400

lsong@georgeinstitute.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Craig Anderson, PhD

Phone

+61 2 8052 4521

canderson@georgeinstitute.org.au

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Craig Anderson, PhD

Organizational Affiliation

The George Institute for Global Health, China

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jianmin Liu

Organizational Affiliation

Changhai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Changhai Hospital

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianmin Liu, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to the research office of The George Institute for Global Health, Sydney Australia.

IPD Sharing Time Frame

Data sharing will be available from 12 months after the publication of the main results.

IPD Sharing Access Criteria

The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research. Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.

IPD Sharing URL

http://georgeinstitute.org.au

Learn more about this trial

Large Artery Occlusion Treated in Extended Time With Mechanical Thrombectomy Trial

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