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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Penumbra Inc.
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT01429350
First received: September 2, 2011
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Penumbra Inc.:

Primary Outcome Measures:
  • Good functional outcome as defined by a modified Rankin score of 0-2 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    The assessor is blinded to patient treatment assignment.

  • Incidence of all serious adverse events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

    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:
  • Good clinical outcome [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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

  • Incidence of symptomatic and asymptomatic intracranial hemorrhage [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 692
Study Start Date: May 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  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
    • Large infarct region >1/3 of the middle cerebral artery territory
    • Evidence of intracranial hemorrhage
  7. Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal
  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. Baseline 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429350

Contacts
Contact: Denise Meyer, MT(ASCP) 281-498-4284 denise.meyer@penumbrainc.com
Contact: Siu P Sit, PhD 510 748-3200 ext 221 siupo.sit@penumbrainc.com

Locations
United States, Colorado
Endovascular Surgical Neuroradiology, Swedish Medical Center Recruiting
Denver, Colorado, United States, 80112
Contact: Don Frei, MD         
Principal Investigator: Don Frei, MD         
United States, Florida
Department of Neurological Surgery Recruiting
Gainesville, Florida, United States, 32610
Contact: Brian Hoh, MD    352-273-9000    brian.hoh@neurosurgery.ufl.edu   
Contact: Adrienne Royster    (352) 273-6980    royster@neurosurgery.ufl.edu   
Principal Investigator: Brian Hoh, MD         
United States, Illinois
Neurosurgery, Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Demetrius Lopes, MD    312-942-6644    dlopes@neurosource.com   
Contact: Corey Woods, RN, MS    312-942-1489    Corey_J_Woods@rush.edu   
Principal Investigator: Demetrius Lopes, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Brian-Fred Fitzsimmons, MD    414-805-9236    bfitzsim@mcw.edu   
Principal Investigator: Brian-Fred Fitzsimmons, MD         
Sponsors and Collaborators
Penumbra Inc.
Investigators
Principal Investigator: J Mocco, MD, MS Vanderbilt University
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

No publications provided

Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT01429350     History of Changes
Other Study ID Numbers: CLP 4338
Study First Received: September 2, 2011
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration

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:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on October 19, 2014