The Safety and Efficacy of Embotrap in Treating Acute Ischemic Stroke Patients

Study Overview
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Brief Summary
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This is a prospective, multicenter, cohort study aiming to compare the safety and efficacy of Embotrap stent retriever to other stent retrievers without inner channel for acute middle cerebral artery occlusion (MCAO). All enrolled patients will be followed up at 90 days after randomization.

Detailed Description
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AIS due to large vessel occlusion (LVO) remains a substantial cause of mortality and morbidity. Recent guidelines have recommended MT as the first-line therapy for AIS-LVO in the anterior circulation. Thrombectomy using a stent retriever is safe and effective in the treatment of AIS. As a new generation of stent retriever, Embotrap stent retriever has a unique design including an open outer cage for clot capture and a closed inner channel for clot stabilization. Previous studies showed Embotrap stent retriever can achieve a successful recanalization of 88% and favorable outcome of 51%. Also, the Multicenter ARISE II Study showed the first-pass effect of EmboTrap stent retriever was 40.1%, higher than other stent retrievers, such as Solitaire FR and Trevo device. But most studies were single-armed without direct comparison. Thus, this prospective cohort study is designed to compare the safety and efficacy of Embotrap stent retriever with other stent retrievers without inner channel.

Official Title
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The Safety and Efficacy of Mechanical Thrombectomy Using Embotrap Stent Retriever in Treating Acute Ischemic Stroke Patients

Conditions
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Stroke, Acute Ischemic Stroke

Intervention / Treatment
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* Device: Embotrap stent retriever
* Device: Solitaire FR, Trevo stent retriever without inner channel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with symptoms due to acute middle cerebral artery occlusion (MCAO) treated with MT with or without intravenous thrombolysis. Premorbid mRS 0-2 Ages 18-80 years NIHSS ≥6 at admission The time from onset to groin puncture ≤ 24 hours ASPECTS 6-10 on non-contrast CT (NCCT) scan, MRI or CT-Perfusion (CTP) Informed consent approved by patients or acceptable patient surrogate. Exclusion Criteria: Any intracranial hemorrhage or severe cerebral infarction on CT or MRI (ASPECTS < 6 points, core infarct volume ≥ 70mL or core infarct area >1/3 middle cerebral artery territory). Severe allergy to contrast media allergy and nitinol Refractory hypertension (SBP > 185 mmHg or DBP > 110 mmHg) Platelet count < 30 x 10^9 / L Coagulopathy history or hemorrhage disorders disease Concurrent participation in a study involving an investigational drug or device that would impact the current study Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy Unable to complete the study and follow-up due to mental disorders, cognitive or emotional disorders Pregnant or lactating women Anticipated life expectancy < 6 months Patients without a legally authorized representative to sign the consent form For other reasons, the researchers believe that the patient is not suitable for enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a multicenter, parallel cohort study. The patients with acute middle cerebral artery occlusion were divided into Embotrap group and control group at a ratio of 1:1 to receive mechanical thrombectomy. The patients in control group will receive thrombectomy using stent retriever without inner channel approved by FDA or NMPA. Several aspects such as first-pass recanalization rate, the successful recanalization rate, and mRS score at 90 days will be compared between the two groups.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embotrap stent retriever<br> | Device: Embotrap stent retriever<br>* Embotrap has a novel design of an open outer cage for clot capture and a closed inner channel for clot stabilization, with great thrombus fixation and anti-escape ability, to improve the successful recanalization rate and good prognosis of patients.<br>|
| Active Comparator: Other stent retriever without endochannel<br> | Device: Solitaire FR, Trevo stent retriever without inner channel<br>* Other stent retriever without inner channel, such as Solitaire FR, Trevo, and other stent retrievers approved by FDA or NMPA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First-pass complete recanalization rate | FPE, eTICI≥2c | intraoperative (After first-pass thrombectomy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First-pass successful recanalization rate | mFPE, eTICI≥2b50 | intraoperative (After first-pass thrombectomy) | 
| Final successful recanalization rate | mFPE, eTICI≥2b50 | intraoperative (Final Digital Subtraction Angiography (DSA) during operation) | 
| Final complete recanalization rate | FPE, eTICI≥2c | intraoperative (Final Digital Subtraction Angiography (DSA) during operation) | 
| 90-day favorable outcome rate | Modified Rankin scale (mRS), the scale runs from 0 to 6, running from perfect health without symptoms to death. 90-day favorable outcome is identified as mRS 0-2. | 90-days (±14days) | 
| The improvement of the NIHSS scores 24 hours after surgery | National Institutes of Health Stroke Scale (NIHSS) | 24 hours after surgery | 
| The improvement of the NIHSS scores 5-7 days after surgery or at discharge | National Institutes of Health Stroke Scale (NIHSS) | 5-7 days after surgery or at discharge, whichever came first | 
| The rescue therapy rate | The rate of rescue therapy, such as balloon dilation, stent implantation, and intra-arterial thrombolysis. | During procedure time | 
| FFR after 5 minutes of mechanical thrombectomy | Fractional flow reserve (FFR) | 5 minutes after successful vessel recanalization. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Embotrap, Acute ischemic stroke, Mechanical thrombectomy, Stent retriever