Status:
COMPLETED
Study to Assess the Safety and Effectiveness of the Penumbra System
Lead Sponsor:
Penumbra Inc.
Conditions:
Stroke
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
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 revasculariz...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00334061
Start Date
June 1 2006
End Date
November 1 2007
Last Update
September 18 2019
Active Locations (1)
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1
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111