Large Artery Occlusion Treated in Extended Time with Mechanical Thrombectomy Trial

NCT ID: NCT05326932

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 382 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-03
• Study Completion Date: 2025-12-31

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Mechanical thrombectomy

Intervention Type: PROCEDURE

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mechanical thrombectomy

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years

2. Present 24-72 hours of stroke onset or last seen well

3. 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

4. National Institute of Health stroke scale (NIHSS) ≥6 at randomisation

5. 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

6. Written informed consent (by patient or proxy, according to local requirements)

Exclusion Criteria

1. 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

2. Major co-morbid disease that could interfere with outcome assessments and follow-up (e.g. cancer, severe heart failure, kidney failure)

3. Pregnancy

4. Unable to undergo a CTP or MRP

5. Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure

6. Seizures at stroke onset or before randomization and baseline NIHSS scores cannot be accurately determined

7. Baseline blood glucose of <50mg/dL (2.78 mmol/L) or >400mg/dL (22.20 mmol/L)

8. Baseline platelet count <50,000/uL

9. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with International normalized ratio (INR) >3

10. Severe, sustained hypertension (systolic blood pressure (BP) >220 mmHg or diastolic BP >120 mmHg)

11. Presumed septic embolus, suspicion of bacterial endocarditis

12. EVT attempted after stroke onset

13. Unlikely to participate in follow-up assessments

14. Currently participating in another trial that may affect outcomes.

15. Any other condition that, in the opinion of the investigator will pose a significant hazard to the subject if participating in the trial.

1. Intracranial hemorrhage (ICH), including parenchymal hemorrhage, ventricular hemorrhage, subarachnoid hemorrhage, and subdural/exsanguination

2. Evidence of intracranial tumor (except small meningioma)

3. Significant mass effect with midline shift

4. Aortic dissection

5. Intracranial stent implanted in the same vascular territory

6. 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

7. 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: collaborator

The George Institute for Global Health, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Anderson, PhD

Role: PRINCIPAL_INVESTIGATOR

The George Institute for Global Health, China

Jianmin Liu

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

Changhai Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Lily Song, PhD

Role: CONTACT

lsong@georgeinstitute.org.cn

+86 13916466400

Craig Anderson, PhD

Role: CONTACT

canderson@georgeinstitute.org.au

+61 2 8052 4521

Facility Contacts

Jianmin Liu, MD

Role: primary

Other Identifiers

LATE-MT

Identifier Type: -

Identifier Source: org_study_id