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Large Artery Occlusion Treated in Extended Time With Mechanical Thrombectomy Trial

ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mechanical thrombectomy

    Procedure/Surgery

    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.

Treatment groups

336 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Functional recovery (level of disability)

A sequence 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 outcomes

1

Neurological function

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±12 hours and 7±1 days
2

Death or major disability

modified Rankin scale (mRS) 3-6

Time frame
90 days
3

Separately on death and disability

modified Rankin scale (mRS) 3-5

Time frame
90 days
4

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.

Time frame
90 days

Other outcomes

1

Intracerebral hemorrhage (ICH)

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

Time frame
7 days and 90 days
2

Death

Death

Time frame
7 days and 90 days
3

Serious adverse events (SAE)

All SAE during follow-up in all randomized patients

Time frame
90 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Changhai Hospital

Collaborator

Source ClinicalTrials.gov
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