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Assess the Penumbra System in the Treatment of Acute Stroke (THERAPY)

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ClinicalTrials.gov Identifier: NCT01429350
Recruitment Status : Completed
First Posted : September 7, 2011
Results First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: intravenous (IV) recombinant human tissue plasminogen activator (rtPA) Device: Penumbra System Phase 4

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The THERAPY Trial: The Randomized, Concurrent Controlled Trial to Assess the Penumbra System's Safety and Effectiveness in the Treatment of Acute Stroke
Study Start Date : May 2012
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: IV rtPA
IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg
 Drug: intravenous (IV) recombinant human tissue plasminogen activator (rtPA)
0.9mg/kg to a maximum of 90mg
Other Name: recombinant tissue plasminogen activator, Alteplase
Experimental: IV rtPA and IA Penumbra System
Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System
 Device: Penumbra System
The Penumbra System is an aspiration based mechanical thrombectomy device


Outcome Measures
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Primary Outcome Measures :
  1. Good Functional Outcome as Defined by a Modified Rankin Score of 0-2 [ Time Frame: 90 days ]
    The assessor is blinded to patient treatment assignment.

  2. Incidence of All Serious Adverse Events [ Time Frame: 90 days ]

    A Serious Adverse Event is defined as an event that:

    1. Led to death

    2. Led to a serious deterioration in the health of the patient that:

      • Resulted in life-threatening illness or injury
      • Resulted in permanent impairment of a body structure or a body function
      • Required in-patient hospitalization or prolongation of existing hospitalization
      • Resulted in medical or surgical intervention to arrest permanent impairment to body structure or a body function
      • Led to fetal distress, fetal death or a congenital abnormality or birth defect


Secondary Outcome Measures :
  1. Good Clinical Outcome [ Time Frame: 30 days ]
    Good clinical outcome at 30 days post-procedure as defined by a 10 points or more improvement in the NIH stroke scale score at Discharge, a NIH stroke scale score of 0-1 at Discharge; or a 30-day modified Rankin scale score of 0-2

  2. Incidence of Symptomatic and Asymptomatic Intracranial Hemorrhage [ Time Frame: 90 days ]
    A symptomatic intracranial hemorrhage is defined as 24 hour CT evidence of an ECASS defined ICH and a 4-point or more worsening of the NIH Stroke Scale score


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429350


Locations
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United States, Colorado
Endovascular Surgical Neuroradiology, Swedish Medical Center
Denver, Colorado, United States, 80112
United States, Florida
Department of Neurological Surgery
Gainesville, Florida, United States, 32610
United States, Illinois
Neurosurgery, Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Penumbra Inc.
Investigators
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Principal Investigator: J Mocco, MD, MS Vanderbilt University Medical Center
Principal Investigator: Pooja Khatri, MD Department of Neurology, University of Cincinnati
Principal Investigator: Osama Zaidat, MD, MSc Neurointerventional Program, Medical College of Wisconsin
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT01429350    
Other Study ID Numbers: CLP 4338
First Posted: September 7, 2011    Key Record Dates
Results First Posted: September 22, 2020
Last Update Posted: September 22, 2020
Last Verified: September 2020
Keywords provided by Penumbra Inc.:
ischemic stroke
acute intervention
thrombolysis
rtPA
internal carotid artery
middle cerebral artery
 mechanical thrombectomy
Penumbra System
clot length
mRS
NIHSS
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Tissue Plasminogen Activator
Plasminogen
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action