Assess the Penumbra System in the Treatment of Acute Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Intervention: intravenous (IV) recombinant human tissue plasminogen activator (rtPA); Penumbra System
Intervention description: 0.9mg/kg to a maximum of 90mg; The Penumbra System is an aspiration based mechanical thrombectomy device
Intervention MeSH terms: Tissue Plasminogen Activator; Plasminogen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: ischemic stroke; acute intervention; thrombolysis; rtPA; internal carotid artery; middle cerebral artery; mechanical thrombectomy; Penumbra System; clot length; mRS; NIHSS

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:

          1. From 18 to 85 years of age

          2. 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

          3. Evidence of a large vessel occlusion in the anterior circulation with a clot length of
             8mm or longer

          4. NIH Stroke Scale (NIHSS) score 8 or greater or aphasic at presentation

          5. Signed informed consent

        Exclusion Criteria:

          1. History of stroke in the past 3 months.

          2. Females who are pregnant

          3. Pre-existing neurological or psychiatric disease that could confound the study results
             such as a pre-stroke mRS score 1 or greater

          4. Known severe allergy to contrast media

          5. Uncontrolled hypertension (defined as systolic blood pressure >185 mmHg or diastolic
             blood pressure >110 mmHg)

          6. 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

          7. 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

          8. Angiographic evidence of preexisting arterial injury

          9. Rapidly improving neurological status prior to randomization

         10. Bilateral stroke

         11. Intracranial tumors

         12. Known history of cerebral aneurysm or arteriovenous malfunction

         13. Known hemorrhagic diathesis, coagulation deficiency, or on anticoagulant therapy with
             an International Normalized Ratio (INR) of >1.7

         14. Baseline platelets <50,000

         15. Use of IV heparin in the past 48 hours with PPT >1.5 times the normalized ratio

         16. Pre-treatment glucose <50mg/dL or >300mg/dL

         17. Life expectancy less than 90 days prior to stroke onset

         18. Participation in another clinical investigation that could confound the evaluation of
             the study device