Assess the Penumbra System in the Treatment of Acute Stroke (NCT01429350) | Clinical Trial Compass
CompletedPhase 4
Assess the Penumbra System in the Treatment of Acute Stroke
United States108 participantsStarted 2012-05
Plain-language 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 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Good Functional Outcome as Defined by a Modified Rankin Score of 0-2
. Uncontrolled hypertension (defined as systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg)
✕. CT evidence of the following conditions at randomization:
✕. 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