Study to Assess the Safety and Effectiveness of the Penumbra System


Phase 2 Results

Eligibility Criteria

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.