Clinical trial NCT05326932: Large Artery Occlusion Treated in Extended Time with Mechanical Thrombectomy Trial
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
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Acute ischemic stroke
Large vessel occlusion
Mechanical thrombectomy
Extended time
Randomised clinical trial
Lead sponsor: The George Institute for Global Health, China
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
First posted: 2022-04-14
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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)

Primary outcomes:
measure: Functional recovery (level of disability)
timeFrame: 90 days
Secondary outcomes:
measure: Neurological impairment
timeFrame: 24 hours and 7 days
measure: Death or major disability
timeFrame: 90 days
measure: Separately on death and disability
timeFrame: 90 days
measure: Health-related Quality of Life (HRQoL)
timeFrame: 90 days
measure: Utility-weighted modified Rankin scale scores
timeFrame: 90 days
measure: Duration of hospitalization
timeFrame: 90 days
measure: Residence
timeFrame: 90 days
measure: Hospital service costs
timeFrame: 90 days
measure: Infarct volume on DWI, or CT
timeFrame: 24 hours
measure: Recanalization
timeFrame: 24 hours after MT
Other outcomes:
measure: Intracerebral hemorrhage (ICH)
timeFrame: 24 hours and 90 days
measure: Death
timeFrame: 7 days and 90 days
measure: Serious adverse events (SAE)
timeFrame: 90 days
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: The George Institute for Global Health, China
name: Craig Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Changhai Hospital
name: Jianmin Liu
role: PRINCIPAL_INVESTIGATOR
References: