Assess the Penumbra System in the Treatment of Acute Stroke

Completed · Phase 4

Conditions studied: Ischemic Stroke

In brief

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 patients with acute ischemic stroke from large vessel occlusion in the brain. IV rtPA is the only drug approved for the treatment of acute ischemic stroke but it does not work very well in cases where the stroke is caused by a large vessel occlusion. The hypothesis being tested is to determine if the addition of a treatment by a mechanical thrombectomy device like the Penumbra System can improve the clinical outcome of the patient over just using IV rtPA alone.

Key facts

Study ID

NCT01429350

Run by

Penumbra Inc.

People needed

108

Starts

2012-05-01

Expected to finish

2016-10-01

Last updated by the study team

2020-09-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Endovascular Surgical Neuroradiology, Swedish Medical Center — Denver, Colorado, United States
• Department of Neurological Surgery — Gainesville, Florida, United States
• Neurosurgery, Rush University Medical Center — Chicago, Illinois, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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