Phase 4
N=108
Assess the Penumbra System in the Treatment of Acute Stroke
Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01429350 ↗Enrolled (actual)
108
Serious AEs
49.5%
Results posted
Sep 2020
Primary outcome: Primary: Good Functional Outcome as Defined by a Modified Rankin Score of 0-2 — 14; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- intravenous (IV) recombinant human tissue plasminogen activator (rtPA) (Drug); Penumbra System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Penumbra Inc.
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Good Functional Outcome as Defined by a Modified Rankin Score of 0-2 |
14; 19 | — |
| PRIMARY Incidence of All Serious Adverse Events |
30; 18 | — |
| SECONDARY Good Clinical Outcome |
17; 24 | — |
| SECONDARY Incidence of Symptomatic and Asymptomatic Intracranial Hemorrhage |
6; 4 | — |
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.
Eligibility Criteria
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 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
- 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 1.5 times the normalized ratio
- Pre-treatment glucose 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
Data sourced from ClinicalTrials.gov (NCT01429350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.