Study to Assess the Safety and Effectiveness of the Penumbra System

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-11-30

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.

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Penumbra System

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No