Therapy Evaluation in Patients With Minor Stroke and Large Vessel Occlusion

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSir Run Run Shaw Hospital

About this trial

This multicenter registry study, which record the therapy strategy and follows up these acute ischemic stroke (AIS) patients with low NIHSS and large vessel occlusion (LVO), is intended to provide the important data for therapy evaluation and prognostic prediction of the LVO patients with low NIHSS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older

Acute ischemic stroke patients of NIHSS 0-5 with 24 hours after onset

Proximal intracranial artery occlusion on NCCT/CTA or MRI/MRA showing occlusion of the intracranial ICA, M1, or proximal M2 vessel

Baseline ASPECTS ≥6 or infarct Core Volume of < 70 on NCCT/DWI/CTP

Disqualifiers

Any sign of intracranial hemorrhage on baseline CT/MR;

Seizures at stroke onset

Baseline blood glucose of <2.78 mmol or >22.20 mmol, or platelet count < 100,000/uL or serum creatinine levels > 3.0 mg/dL

Participation in any investigational study in the previous 30 days

Trial population

Acute ischemic stroke patients with minor stroke (NIHSS 0-5) and large artery occlusion.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Immediate endovascular therapy

    Other intervention

    The best medical therapy includes intravenous fibrinolysis, anticoagulants or antiplatelet, but NOT any immediate endovascular therapies.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Immediate Endovascular Therapy1 intervention
Group B: Best Medical Therapy0 interventions

Trial outcomes

Primary outcomes

1

modified Rankin Scale at 90 days

modified Rankin Scale at 90 days

Time frame
90 days
2

acute neurological deterioration

It is neurological deterioration of presumed ischemic origin with an NIHSS score increase of 4 points or more within the 24 hours after onset.

Time frame
24 hours

Secondary outcomes

1

Incidence of symptomatic intracerebral hemorrhage

Incidence of symptomatic intracerebral hemorrhage according to ECASS II criteria

Time frame
2-3 days
2

patients with good outcome comparing the two treatment groups

Good outcome is defined as a score of 0-2 on the 90-day mRS

Time frame
90 days

Other outcomes

Sponsors and contacts

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