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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT01429350
First received: September 2, 2011
Last updated: November 6, 2014
Last verified: November 2014

September 2, 2011
November 6, 2014
May 2012
October 2016   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01429350 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Assess the Penumbra System in the Treatment of Acute Stroke
The THERAPY Trial: The Randomized, Concurrent Controlled Trial to Assess the Penumbra System's Safety and Effectiveness in the Treatment of Acute Stroke

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ischemic Stroke
  • Drug: intravenous (IV) recombinant human tissue plasminogen activator (rtPA)
    0.9mg/kg to a maximum of 90mg
    Other Name: recombinant tissue plasminogen activator, Alteplase
  • Device: Penumbra System
    The Penumbra System is an aspiration based mechanical thrombectomy device
  • Active Comparator: IV rtPA
    IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg
    Intervention: Drug: intravenous (IV) recombinant human tissue plasminogen activator (rtPA)
  • 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
    Intervention: Device: Penumbra System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
692
December 2016
October 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01429350
CLP 4338
Yes
Penumbra Inc.
Penumbra Inc.
Not Provided
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
Penumbra Inc.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP