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Endovascular Treatment for Acute Large Vessel Occlusion With Ultra-Large Ischemic Core

ConditionsAISStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Harbin Medical University

About this trial

an investigator initiated, prospective, multicenter, randomized, open-label, blinded endpoint trial (PROBE)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years.

Symptoms onset or Time last known well ≤ 24 h from randomization.

Acute ischemic stroke due to an occlusion of the intracranial internal carotid artery, M1 or proximal M2 segment of the middle cerebral artery confirmed by CTA or MRA.

NCCT or diffusion-weighted imaging (DWI) demonstrating ASPECTS ≤ 2 or infarct core volume (defined as rCBF <30% on CTP) ≥ 100 mL.

Disqualifiers

Evidence of intracranial hemorrhage on CT/MRI, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, or subdural/epidural hemorrhage.

Cerebral midline shift or herniation, or other ventricular mass effect with midline shift as confirmed on CT/MRI.

Bilateral anterior circulation or acute multi-vessel occlusion involving both anterior and posterior circulation, confirmed by CTA or MRA.

Blood pressure >185/110 mmHg and is refractory to medicine.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Patients assigned to the EVT group should undergo EVT as soon as possible, followed by BMM according to the current EVT guidelines.

    Procedure/Surgery

    EVT should be performed as soon as possible in patients randomized to the EVT group. Investigators and clinicians should make every effort to minimize delays related to pre-procedural preparation, with a target interval of no more than 60 minutes from randomization to arterial puncture. EVT in the EVT group can be performed with any thrombectomy device (NMPA approved) usually used at study site.

  • The medical group receives BMM alone. EVT is not performed in the medical group.

    Drug

    The administration of medications is at the treating physician's discretion (for example intravenous fibrinolysis, anticoagulants or antiplatelet) according to current AIS management guidelines but may NOT include any intra-arterial therapies.

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: EVT groupExperimental treatment 1 intervention
Group B: Medical groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The primary efficacy endpoint is the mRS score at 90 days after randomization.

Time frame
at 90 days after randomization.

Secondary outcomes

1

mRS score at 180 days after randomization.

Time frame
at 180 days after randomization.
2

Proportion of mRS 0-2 at 90 days and 180 days after randomization.

Time frame
at 90 days and 180 days after randomization.
3

Proportion of mRS 0-3 at 90 days and 180 days after randomization.

Time frame
at 90 days and 180 days after randomization.
4

Proportion of early neurological improvement

Time frame
at day 7 (±1) or discharge (whichever is earlier).

Other outcomes

1

Incidence of all-cause mortality within 90 days after randomization.

Time frame
within 90 days after randomization.
2

Incidence of symptomatic intracranial hemorrhage (sICH, per Heidelberg Bleeding Classification) at 24±12 hours from onset.

Time frame
at 24±12 hours from onset.
3

Incidence of early neurological deterioration

Time frame
defined as a NIHSS increase ≥ 10 points at day 7 (±1) or discharge (whichever is earlier). Death within 7 days of onset is directly judged as neurological deterioration.
4

Procedure- or device-related complications

Time frame
perioperative period

Sponsors and contacts

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

First Affiliated Hospital of Harbin Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: