Status:
COMPLETED
Assess the Penumbra System in the Treatment of Acute Stroke
Lead Sponsor:
Penumbra Inc.
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The purpose of this trial is to assess the safety and effectiveness of the Penumbra System as an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator (rtPA)in patien...
Detailed Description
Current therapies for acute stroke are limited to the intravenous administration of a intravenous (IV) recombinant human tissue plasminogen activator (rtPA) for thrombolysis of the affected cerebral a...
Eligibility Criteria
Inclusion
- From 18 to 85 years of age
- Present with symptoms consistent with an acute ischemic stroke and eligible for IV rtPA therapy (patients presenting 3-4.5 hrs from symptom onset are not eligible if they are \>80 yrs of age, have a history of stroke and diabetes, anticoagulant use (even if INR is \<1.7) and have a NIHSS score \>25
- Evidence of a large vessel occlusion in the anterior circulation with a clot length of 8mm or longer
- NIH Stroke Scale (NIHSS) score 8 or greater or aphasic at presentation
- Signed informed consent
Exclusion
- History of stroke in the past 3 months.
- Females who are pregnant
- Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score 1 or greater
- Known severe allergy to contrast media
- Uncontrolled hypertension (defined as systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg)
- CT evidence of the following conditions at randomization:
- Significant mass effect with midline shift
- Any acute ischemic changes in \>1/3 of the affected middle cerebral artery territory
- Evidence of intracranial hemorrhage
- Angiographic evidence of tantem extracranial occlusion or an arterial stenosis proximal to the occlusion that requires treatment prior to thrombus removal. Moderate stenosis not requiring treatment is not an exclusion
- Angiographic evidence of preexisting arterial injury
- Rapidly improving neurological status prior to randomization
- Bilateral stroke
- Intracranial tumors
- Known history of cerebral aneurysm or arteriovenous malfunction
- Known hemorrhagic diathesis, coagulation deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of \>1.7
- Baseline platelets \<50,000
- Use of IV heparin in the past 48 hours with PPT \>1.5 times the normalized ratio
- Pre-treatment glucose \<50mg/dL or \>300mg/dL
- Life expectancy less than 90 days prior to stroke onset
- Participation in another clinical investigation that could confound the evaluation of the study device
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01429350
Start Date
May 1 2012
End Date
October 1 2016
Last Update
September 22 2020
Active Locations (4)
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1
Endovascular Surgical Neuroradiology, Swedish Medical Center
Denver, Colorado, United States, 80112
2
Department of Neurological Surgery
Gainesville, Florida, United States, 32610
3
Neurosurgery, Rush University Medical Center
Chicago, Illinois, United States, 60612
4
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226