NCT01429350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2012

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
4 years until next milestone

Results Posted

Study results publicly available

September 22, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

4.4 years

First QC Date

September 2, 2011

Results QC Date

March 4, 2019

Last Update Submit

September 18, 2020

Conditions

Ischemic Stroke

Keywords

ischemic strokeacute interventionthrombolysisrtPAinternal carotid arterymiddle cerebral arterymechanical thrombectomyPenumbra Systemclot lengthmRSNIHSS

Outcome Measures

Primary Outcomes (2)

  • Good Functional Outcome as Defined by a Modified Rankin Score of 0-2

    The assessor is blinded to patient treatment assignment.

    90 days

  • Incidence of All Serious Adverse Events

    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

    90 days

Secondary Outcomes (2)

  • Good Clinical Outcome

    30 days

  • Incidence of Symptomatic and Asymptomatic Intracranial Hemorrhage

    90 days

Study Arms (2)

IV rtPA

ACTIVE COMPARATOR

IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg

Drug: intravenous (IV) recombinant human tissue plasminogen activator (rtPA)

IV rtPA and IA Penumbra System

EXPERIMENTAL

Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System

Device: Penumbra System

Interventions

intravenous (IV) recombinant human tissue plasminogen activator (rtPA)DRUG

0.9mg/kg to a maximum of 90mg

Also known as: recombinant tissue plasminogen activator, Alteplase
IV rtPA
Penumbra SystemDEVICE

The Penumbra System is an aspiration based mechanical thrombectomy device

IV rtPA and IA Penumbra System

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • From 18 to 85 years of age
  • 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
  • Evidence of a large vessel occlusion in the anterior circulation with a clot length of 8mm or longer
  • NIH Stroke Scale (NIHSS) score 8 or greater or aphasic at presentation
  • Signed informed consent

You may not qualify if:

  • History of stroke in the past 3 months.
  • Females who are pregnant
  • Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score 1 or greater
  • Known severe allergy to contrast media
  • Uncontrolled hypertension (defined as systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg)
  • 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
  • Angiographic evidence of preexisting arterial injury
  • Rapidly improving neurological status prior to randomization
  • Bilateral stroke
  • Intracranial tumors
  • Known history of cerebral aneurysm or arteriovenous malfunction
  • Known hemorrhagic diathesis, coagulation deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of \>1.7
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Endovascular Surgical Neuroradiology, Swedish Medical Center

Denver, Colorado, 80112, United States

Location

Department of Neurological Surgery

Gainesville, Florida, 32610, United States

Location

Neurosurgery, Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • Yoo AJ, Khatri P, Mocco J, Zaidat OO, Gupta R, Frei D, Lopes D, Shownkeen H, Berkhemer OA, Meyer D, Hak SS, Kuo SS, Buell H, Bose A, Sit SP, von Kummer R; THERAPY Trial Investigators. Impact of Thrombus Length on Outcomes After Intra-Arterial Aspiration Thrombectomy in the THERAPY Trial. Stroke. 2017 Jul;48(7):1895-1900. doi: 10.1161/STROKEAHA.116.016253. Epub 2017 Jun 8.

    PMID: 28596447DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Results Point of Contact

Title
Michaella Corso
Organization
Penumbra, Inc.
mcorso@penumbrainc.com
510-995-2079

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2011

First Posted

September 7, 2011

Study Start

May 1, 2012

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

September 22, 2020

Results First Posted

September 22, 2020

Record last verified: 2020-09

Locations

US(4)