Large Artery Occlusion Treated in Extended Time With Mechanical Thrombectomy Trial

Acute Ischemic Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326932
• Other study ID #: LATE-MT
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: January 30, 2025

Study information

• Verified date: February 2023
• Source: The George Institute for Global Health, China
• Contact: Lily Song, PhD
• Phone: +86 13916466400
• Email: lsong[@]georgeinstitute.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 382
• Est. completion date: January 30, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Clinical 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.

Neuroimaging Exclusion Criteria

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)

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
The George Institute for Global Health, China	Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intracerebral hemorrhage (ICH)	a) symptomatic ICH, based on previous criteria; b) ICH of any type in brain imaging	24 hours and 90 days
Other	Death	Death	7 days and 90 days
Other	Serious adverse events (SAE)	All SAE during follow-up in all randomized patients	90 days
Primary	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.	90 days
Secondary	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.	24 hours and 7 days
Secondary	Death or major disability	modified Rankin scale (mRS) 3-6	90 days
Secondary	Separately on death and disability	modified Rankin scale (mRS) 3-5	90 days
Secondary	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.	90 days
Secondary	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.	90 days
Secondary	Duration of hospitalization	Days of hospitalization	90 days
Secondary	Residence	Days of residence	90 days
Secondary	Hospital service costs	Health economic measurement	90 days
Secondary	Infarct volume on DWI, or CT	Infarct volume on DWI, or CT if DWI not feasible	24 hours
Secondary	Recanalization	Recanalization confirmed on imaging	24 hours after MT