Prospective Evaluation to Characterize the Real-World Performance of the EMBOVAC Aspiration Catheter

Study Overview
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Brief Summary
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A post-market study evaluating the EMBOVAC Aspiration Catheter in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.

Detailed Description
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The PERFECT Study is a prospective, multi-center, single arm, post-market clinical follow-up study. The objective of this post-market clinical follow-up study is to assess the performance of the EMBOVAC Aspiration Catheter in the treatment of acute ischemic stroke in a real-world clinical setting. The study will also report on clot characteristics and clinical outcomes.

Official Title
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Prospective Evaluation to Characterize the Real-World Performance of the EMBOVAC Aspiration Catheter for Neurothrombectomy: A Post-Market Clinical Follow-up Trial.

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Device: EMBOVAC Aspiration Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject ≥ 18 years old. Subject experiencing acute ischemic stroke with angiographic confirmation of Large Vessel Occlusion of the distal intracranial internal carotid artery, middle cerebral artery or anterior cerebral artery A clinical decision has been made to use the EMBOVAC™ aspiration catheter prior to enrollment in the research EMBOVAC™ Aspiration Catheter is attempted to be used for the first 3 clot removal passes for the target intracranial occlusion Pre-stroke mRS ≤ 1 NIHSS ≤ 30 Informed Consent has been provided by the subject or the subject's legally authorized representative. Exclusion Criteria Potential study candidate has already undergone standard of care assessments or treatment that deviate from the clinical research protocol requirements All patients with severe hypertension on presentation. All patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous antihypertensive therapy Known cerebral vasculitis. Known cancer with life expectancy less than 12 months. Stenosis, or any occlusion, in a vessel proximal to the target occlusion that requires treatment or prevents access to the site of occlusion. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation. Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma). Evidence of dissection in the extra or intracranial cerebral arteries. Occlusions in multiple vessels. Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication). Currently participating in an investigational clinical trial that may confound study endpoints.

Ages Eligible for Study
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Minimum Age: 18 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

| Intervention/Treatment |
| --- |
|Device: EMBOVAC Aspiration Catheter|The EMBOVAC Aspiration catheter is used to treat acute ischemic stroke. The catheter can be used to facilitate introduction of diagnostic or therapeutic agents and is also intended for use in removal/aspiration of emboli and thrombi from selected blood vessels in the neuro vasculature.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Revascularization |  | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Revascularization without rescue |  | 1 Day | 
| Complete Revascularization |  | 1 Day | 
| First Pass Effect |  | 1 Day | 
| Time to recanalization |  | 1 Day | 
| Modified Rankin Scale |  | 90 Day | 
| Device related serious adverse events |  | 90 Days | 
| Symptomatic Intracerebral Hemorrhage at 24 hours |  | 24 Hours | 
| NIHSS at 24 hours |  | 24 Hours | 
| 90 Day all-cause mortality |  | 90 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Ischemic Stroke, perfect, embovac