Amnis Therapeutics Thrombectomy Device-First in Man (FIM) Safety and Performance Study

Study Overview
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Brief Summary
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Prospective, single-arm, open label, Safety and Performance clinical investigation.

Detailed Description
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The Amnis Thrombectomy Device is intended to restore blood flow by removing thrombus from intracranial vessels in patients experiencing ischemic stroke. Pre-CE mark clinical investigation. Population will be subjects with documented untreated, acute ischemic stroke with large vessel occlusion.

Official Title
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Amnis Therapeutics Thrombectomy Device-First in Man (FIM) Safety and Performance Study

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: Thrombectomy Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged18-85years. Subject who is contraindicated or failed (when the physician withdraws the tPA per physician discretion) intravenous tissue plasminogen activator (t-PA) therapy given at local institutions or within national practice. Failed means that the physician does not continue with IV tPA after thrombolysis; there is still an occlusion with TICI that is </= 1 as the relevant inclusion criteria. Subject is able to be treated within 8 hours of stroke symptoms onset with minimum of one deployment of the Amnis Thrombectomy Device. NIHSS score ≥8. Pre-stroke mRS (modified Rankin Scale) score of 0 to 1. Thrombolysis in cerebral infarction (TICI) ≤1 and causative occlusion of the M1 or M2 portion of the MCAs, anterior cerebral arteries, vertebral arteries, basilar artery ,or posterior cerebral arteries (P1 o rP2), confirmed by CT or MR angiography that is accessible to the Amnis thrombectomy device (i.e. according to IFU; 2-5.5 mm). ASPECTS of ≥6 based on CT or MRI that was performed within 60 min prior to the start of endovascular procedure. Subject or subject's legal guardian where regulations permit, signs the Patient Informed Consent and agrees that subject will attend follow-up visits. Exclusion Criteria: Rapid neurological improvement prior to or at time of treatment suggesting resolution of signs/symptoms of stroke. Estimated time of symptom onset. Baseline NIHSS score <8. BaselineNIHSS score ≥30 or state of coma. Baseline pre-stroke mRS score >1. Baseline Thrombolysis in cerebral infarction (TICI) > 2a. Known serious sensitivity to radiographic contrast agent. Arterial tortuosity, pre-existing stent and/o rother arterial disease that would prevent the device from reaching the target vessel. Evidence of a moderate/large core defined as extensive early ischemic changes of Alberta Stroke Program Early CT score (ASPECTS) <6. Co-morbid conditions: Elevated blood pressure(systolic>185 mm Hg or diastolic >110 mm Hg) Use of warfarin anticoagulation with INR >3.0. Platelet count <30,000/mm³. Blood glucose concentration <50 mg/dL (2.7 mmol/L). CT/MRI imaging demonstrate smultilobar infarction (hypodensity >1/3 cerebral hemisphere). CT or MRI evidence of mass effect, signs of hemorrhage, arteriovenous malformation or aneurysm or intra-cranial tumor (except small meningioma). Angiographic evidence of carotid dissection, complete cervical carotid occlusions or vasculitis. Clinical Symptoms or CT/MRI imaging suggest subarachnoid hemorrhage. Imaging evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target lesion, moderate/large infarct with poor collateral circulation, etc.). General - related to the protocol or device: Known sensitivity to nickel, titanium metals or their alloys. Subject who requires hemodialysis or peritoneal dialysis, or who has a contraindication to an angiogram for whatever reason. Current participation in another investigational drug or device study. Female who is pregnant or lactating or has a positive pregnancy test at time of admission. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day). Subject has a life expectancy of <90 days. Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open arm<br>Thrombectomy device to be used to retrieve clot and restore blood flow. | Device: Thrombectomy Device<br>* The Amnis Thrombectomy Device is intended to restore blood flow by removing thrombus from intracranial vessels in patients experiencing ischemic stroke<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All serious adverse events (notably at 24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first). | It will investigate whether the application of Amnis Thrombectomy device is a safe method, in acute stroke therapy, for obtaining recanalization of large vessels and with favorable patient outcome. | 24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first. | 
| All cause mortality (90 days). | Determine the number of participants with treatment-related adverse events. | 3 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial recanalization of the occluded target vessel in the immediate post-procedure angiogram. | Arterial recanalization of the occluded target vessel as angiographically scored by a Thrombolysis in Cerebral Infarction (TICI) flow grade of 2b or greater in the immediate post-procedure angiogram. | Immediate post-procedure angiogram. | 
| Proportion of patients with rapid neurological improvement as determined by a NIHSS ≤4. | Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS or NIHSS ≤4) during the first 24 hours after treatment. | First 24 hours after treatment | 
| Good functional clinical outcome as determine by a modified Rankin Scale score of 0-2. | Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS or NIHSS ≤4) during the first 24 hours after treatment. | First 24 hours after treatment. |