Assess the Penumbra System in the Treatment of Acute Stroke

Last updated: September 18, 2020
Sponsor: Penumbra Inc.
Overall Status: Completed

Phase

4

Condition

Stroke

Cerebral Ischemia

Thrombosis

Treatment

N/A

Clinical Study ID

NCT01429350
CLP 4338
  • Ages 18-85
  • All Genders

Study 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

Inclusion Criteria:

  1. From 18 to 85 years of age

  2. Present with symptoms consistent with an acute ischemic stroke and eligible for IVrtPA therapy (patients presenting 3-4.5 hrs from symptom onset are not eligible ifthey 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

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 resultssuch 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 diastolicblood 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 arteryterritory

  • Evidence of intracranial hemorrhage

  1. Angiographic evidence of tantem extracranial occlusion or an arterial stenosisproximal to the occlusion that requires treatment prior to thrombus removal. Moderatestenosis not requiring treatment is not an exclusion

  2. Angiographic evidence of preexisting arterial injury

  3. Rapidly improving neurological status prior to randomization

  4. Bilateral stroke

  5. Intracranial tumors

  6. Known history of cerebral aneurysm or arteriovenous malfunction

  7. Known hemorrhagic diathesis, coagulation deficiency, or on anticoagulant therapy withan International Normalized Ratio (INR) of >1.7

  8. Baseline platelets <50,000

  9. Use of IV heparin in the past 48 hours with PPT >1.5 times the normalized ratio

  10. Pre-treatment glucose <50mg/dL or >300mg/dL

  11. Life expectancy less than 90 days prior to stroke onset

  12. Participation in another clinical investigation that could confound the evaluation ofthe study device

Study Design

Total Participants: 108
Study Start date:
May 01, 2012
Estimated Completion Date:
October 31, 2016

Study 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 arteries within 3-4.5 hours from symptom onset, and the use of intra-arterial (IA) endovascular mechanical clot retrieval devices within 8 hours from ictus, all of which have limitations as mono therapies. For example, IV rtPA may not be very efficacious in large vessel occlusion and the long term effects of mechanical thrombectomy devices on patient functional outcome is unknown. This is a randomized, concurrent controlled study to assess the safety and effectiveness of the Penumbra System as adjunctive therapy to IV rtPA in the acute intervention of acute ischemic stroke. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large clot burden (clot length > 8mm) in the anterior circulation will be assigned to either IV rtPA therapy alone (0.9mg/kg to a maximum of 90mg) or a combined IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and intra-arterial (IA) adjunctive treatment with the Penumbra System. Each treated patient will be followed and assessed for 3 months after enrollment.

Connect with a study center

  • Endovascular Surgical Neuroradiology, Swedish Medical Center

    Denver, Colorado 80112
    United States

    Site Not Available

  • Department of Neurological Surgery

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Neurosurgery, Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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