First-pass Recanalization With EmboTrap II in Acute Ischemic Stroke (FREE-AIS)

Study Overview
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Brief Summary
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This study is a prospective, open-label, multi-center, registry study, designed to to documents that EmboTrap II usage as a thrombectomy device for emergency large vessel occlusion (ELVO) in terms of the rate of First Pass Recanalization (FPR). Patients with ELVO will initially underwent mechanical thrombectomy usig EmboTrap II. FPR is defined as modified Tissue Thrombolysis In Cerebral Ischemia (mTICI) 2b or 3

Official Title
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First-pass Recanalization With EmboTrap II in Acute Ischemic Stroke (FREE-AIS)

Conditions
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Acute Ischemic Stroke Due to Intracranial Large Artery Occlusion

Intervention / Treatment
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* Device: Thrombectomy using EmboTrap II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects experiencing acute ischemic stroke due to large vessel occlusion (intracranial internal carotid artery and middle cerebral artery M1 or proximal M2 segment, intracranial vertebral artery and basilar artery Age 19 or greater mRS before qualifying stroke, 0 to 2 Baseline NIHSS score 4 or more CT ASPECTS > 5 or MR ASPECTS > 4 Good collateral statues on CT angiogram (collateral grade by Calgary group, 4 or 5) or corresponding to DEFUSE 3 or DAWN trial on perfusion imaging. Onset (last-seen-well) time to femoral puncture time < 24 hours Anticipated life expectancy of at least 12 months Patients who undergo endovascular thrombectomy with EmboTrap II as the first-line device Signed informed consent for study enrollment Exclusion Criteria: Multiple simultaneous large vessel occlusions Pregnancy Severe contrast allergy or absolute contraindication to iodinated contrast agent Patient has a severe or fatal combined illness that will prevent improvement of follow-up or will render the procedure unlikely to benefit the patient.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rescue stenting group<br> | Device: Thrombectomy using EmboTrap II<br>* The subjects will receive endovascular treatment for acute stroke according to standard clinical practice. Specifically, using a stent retriever, contact aspiration EmboTrap II. The number of thrombectomy attempts is at the operator's discretion. Combination of balloon guide catheter or intermediate catheter is recommended.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Pass Recanalization (FPR) rate | The rate of FPR defined by modified TICI 2b or 3 | Within 1 day after the completion of endovascular thrombectomyh | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of modified Rankin scale 0-2 at 3 months after treatment | The rate of modified Rankin Scale score (mRS), 0-2 at 90 days ± 14 days | 90 days ± 14 days |