Study to Assess the Safety and Effectiveness of the Penumbra System

Phase 2

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Device-related and Procedure-related Serious Adverse Events	3-Month Post-Procedure
Percentage of Participants With Revascularization of the Occluded Target Vessel	3-Month Post-Procedure	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment	90-Day	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.
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	Discharge or 30-Days Post-Procedure	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.
Percentage of Participants With All Cause Mortality	90-Days Post-Treatment
Percentage of Participants With Symptomatic Hemorrhage	24-Hour Post-Procedure	All treated patients were scanned by computed tomography (CT) at 24-hours post-procedure to detect the presence of intracranial hemorrhage.