Study to Assess the Safety and Effectiveness of the Penumbra System

Study Overview
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Brief Summary
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This clinical evaluation is a prospective, single-arm, multi-center trial. The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.

Detailed Description
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Purpose: The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease. Up to 125 evaluable patients will be enrolled in the study.

Official Title
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Evaluation of the Penumbra™ Stroke System in the Revascularization of Patients With Acute Ischemic Stroke Secondary to Intracranial Large Vessel Occlusive Disease

Conditions
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Stroke

Intervention / Treatment
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* Device: Penumbra System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical signs consistent with acute ischemic stroke 18 to 79 years of age Neurological deficit resulting in an NIH Stroke Scale (NIHSS) score > 8 TIMI 0 or TIMI I flow in vessels accessible to the Penumbra System Signed informed consent Present within 8 hours of stroke symptom onset; ineligible or refractory to intravenous tissue plasminogen activator (t-PA) therapy if presenting within 3 hours of symptom onset. Exclusion Criteria: Evidence of rapidly improving neurological signs of stroke at time of enrollment NIHSS > 30 or coma Females who are pregnant Vessel tortuosity too difficult to allow endovascular access Known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an International Normalized Ratio (INR) > 3.0 Partial thromboplastin time (PTT) greater than 2 times the lab normal Admission platelets < 30,000 Pre-existing neurological or psychiatric disease that could confound the study results Known severe allergy to contrast media Uncontrolled hypertension Computed tomography (CT) evidence of significant mass effect with a midline shift CT reveals evidence of large hypodensity region > 1/3 of the middle cerebral artery territory CT reveals evidence of intracranial hemorrhage CT reveals significant mass effect with midline shift Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal Angiographic evidence of preexisting arterial injury Life expectancy of less than 90 days Participation in another clinical investigation that could confound the evaluation of the study device.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Penumbra System|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Revascularization of the Occluded Target Vessel | Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System. TIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow. | 3-Month Post-Procedure | 
| Percentage of Participants With Device-related and Procedure-related Serious Adverse Events |  | 3-Month Post-Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Either a 4-point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment | NIHSS is a 42 point scale to describe the neurological status of the patients: 0=no stroke; 1-15=minor to moderate stroke; 15-20=moderate/severe stroke; 21-42=severe stroke. The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death. | Discharge or 30-Days Post-Procedure | 
| Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment | The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death. | 90-Day | 
| Percentage of Participants With All Cause Mortality |  | 90-Days Post-Treatment | 
| Percentage of Participants With Symptomatic Hemorrhage | All treated patients were scanned by computed tomography (CT) at 24-hours post-procedure to detect the presence of intracranial hemorrhage. | 24-Hour Post-Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Penumbra, Ischemic, Stroke, Intervention, Neurovascular, Thrombus, Embolectomy, Ischemic stroke