ThrombX Retriever for Acute Ischemic Stroke Trial

Study Overview
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Brief Summary
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This trial is designed to assess the safety and effectiveness of the ThrombX Retriever.

Detailed Description
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This trial is a clinical evaluation is to assess the safety and effectiveness of the ThrombX Retriever in the revascularization of the site of primary occlusion in patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.

Official Title
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ThrombX Retriever for Acute Ischemic Stroke Trial

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: Mechanical thrombectomy with ThrombX Retriever


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute anterior circulation ischemic stroke Pre-stroke Modified Rankin Score ≤ 1 NIHSS ≥ 6 and < 25 immediately prior to enrollment ASPECT score ≥6 with CT scanning or core infarct volume <50 mL on magnetic MRI or CT based perfusion imaging Occlusion of IC or the middle cerebral artery M1 or M2 division Subject can be treated within eight-hours of onset of stroke symptoms Exclusion Criteria: Pregnant or lactating at time of admission Known serious sensitivity to radiographic contrast agents Known sensitivity to nickel, titanium metals, or their alloys Current participation in another investigation drug or device treatment study Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency prothrombin time lab results to be available prior to enrollment) Renal failure Baseline blood glucose of <50mg/dL (2.78 mmol/L) or >400mg/dL (22.20 mmol/L) Baseline platelet count < 50,000/uL Severe, sustained hypertension Presumed septic embolus, suspicion of bacterial endocarditis Subject has a contraindication to an angiogram Life expectancy <6 months Comorbid disease or condition that would confound assessments Known history of arterial tortuosity, preexisting stent, and/or other arterial disease Tandem lesions, occlusion requiring angioplasty and/or stent placement or evidence of carotid dissection Site of occlusion is heavily calcified Imaging or clinical evidence of bilateral strokes or concomitant posterior circulation stroke CT or MRI evidence of hemorrhage or evidence of mass effect or intra-cranial tumor Imaging evidence suggests subject is not appropriate for mechanical thrombectomy

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
Interventional Model Description: Single group assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ThrombX Retriever<br>Access to the involved vasculature and preform mechanical thrombectomy using the ThrombX Retriever. | Device: Mechanical thrombectomy with ThrombX Retriever<br>* Revascularization<br>* Other names: Mechanical Thrombectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful reperfusion of the occluded target vessel with up to 3 passes of the ThrombX Retriever | Defined by a mTICI score >2b | Up to the end of theprocedure | 
| Safety Endpoint | Symptomatic intracerebral hemorrhage (sICH) confirmed on imaging and other Serious Adverse Device Effects (SADE) within 24 hours post procedure. The sICH is defined as the presence of extravascular blood in the cranium associated with an increase in the NIHSS score of ≥ 4 points or death. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional independence defined by modified Rankin Scale (mRS) | modified Ranking Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. | 90 Days |