Interventional Management of Stroke (IMS) III Trial (IMSIII)

This study has been terminated.
(NINDS/NIH-DSMB recommended halting trial due to futility, no safety concerns.)
Sponsor:
Collaborators:
Medical University of South Carolina
University of Calgary
Information provided by (Responsible Party):
Joseph Broderick, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00359424
First received: July 31, 2006
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to compare two different treatment approaches to recanalization started within 3 hours of symptom onset—combined intravenous (IV) and endovascular therapy and standard intravenous (IV) rt-PA alone.


Condition Intervention Phase
Stroke
Drug: IV rt-PA alone
Other: endovascular therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interventional Management of Stroke Trial (IMS III): A Phase III Clinical Trial Examining Whether a Combined Intravenous (IV) and Intra-Arterial (IA) Approach to Recanalization is Superior to Standard IV Rt-PA (Activase®) Alone

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. [ Time Frame: at 90 days post randomization ] [ Designated as safety issue: No ]
    The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.

  • Death Due to Any Cause [ Time Frame: within 90 days post randomization ] [ Designated as safety issue: Yes ]
  • Symptomatic Intracranial Hemorrhage [ Time Frame: within the first 30 hours post IV rt-PA ] [ Designated as safety issue: Yes ]
    Symptomatic Intracranial Hemorrhage- Symptomatic ICH is defined as an intracranial hemorrhage temporally related to a decline in neurological status as well as new or worsening neurologic symptoms in the judgment of the clinical investigator and which may warrant medical intervention. These events are identified via Adverse Event CRF submitted by the site


Secondary Outcome Measures:
  • Incidence of Parenchymal Type II (PH2) Hematomas [ Time Frame: within 30 hours post IV rt-PA ] [ Designated as safety issue: Yes ]
    a dense intracerebral hematoma involving more than 30% of the infarcted area with substantial space-occupying effect or any hemorrhagic area outside the infarcted area, determined via central read of the submitted CT scans.

  • Asymptomatic Intracranial Hemorrhage [ Time Frame: within 30 hours post IV rt-PA ] [ Designated as safety issue: Yes ]
    Asymptomatic intracranial hemorrhage is defined as an intracranial hemorrhage without evidence of decline in neurological status or new or worsening neurologic symptoms in the judgment of the clinical investigator. These events are identified via Adverse Event CRF submitted by the site.

  • National Institutes of Health Stroke Scale Score (NIHSS) >> Dichotomized 0-1 Versus 2 or Greater. [ Time Frame: at 24 hours post randomization ] [ Designated as safety issue: No ]

    The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that >> quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher

    >> scores indicating greater severity of deficit.


  • National Institutes of Health Stroke Scale Score (NIHSS) Dichotomized 0-1 Versus 2 or Greater. [ Time Frame: at 90 days post randomization ] [ Designated as safety issue: No ]
    The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher scores indicating greater severity of deficit.

  • Barthel Index (BI) Dichotomized 0-90 Versus 95-100 [ Time Frame: at 90 days post randomization ] [ Designated as safety issue: No ]
    The Barthel Index (BI)is an ordinal scale used to measure a subject's performance in activities of daily living (ADL) in ten variables- feeding, transfer (bed to chair), grooming, toilet use, bathing, mobility on a level surface, stair use, dressing, bowels and bladder. It is an assessment of independence in ADL and is scored in increments of 5 points. The lowest possible score on the index is 0 which implies total dependence on others for ADL and the highest total score is 100 which indicate full independent in ADL. A higher score is associated with a greater likelihood of being able to live at home with a degree of independence.

  • Trail Making Test Part A Time [ Time Frame: 90 days post randomization ] [ Designated as safety issue: No ]
    The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a "trail" made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes.

  • Trail Making Test Part B Time [ Time Frame: at 90 days post randomization ] [ Designated as safety issue: No ]
    The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a "trail" made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes.

  • Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2 [ Time Frame: at 180 days ] [ Designated as safety issue: No ]
    The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.

  • Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2 [ Time Frame: 270 days ] [ Designated as safety issue: No ]
    The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.

  • Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2 [ Time Frame: 360 days post randomization ] [ Designated as safety issue: No ]
    The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.


Enrollment: 656
Study Start Date: August 2006
Study Completion Date: April 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: intravenous (IV) rt-PA alone
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
Drug: IV rt-PA alone
Intravenous (IV) recombinant tissue plasminogen activator (rt-PA) is the only approved acute stroke therapy; Group one will receive the standard dose of IV rt-PA given over an hour.
Other Name: Activase®, Actilyse®
Experimental: Endovascular therapy
Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
Drug: IV rt-PA alone
Intravenous (IV) recombinant tissue plasminogen activator (rt-PA) is the only approved acute stroke therapy; Group one will receive the standard dose of IV rt-PA given over an hour.
Other Name: Activase®, Actilyse®
Other: endovascular therapy
Group two will receive a lower dose or the standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery. Endovascular therapy can be implemented with or without interarterial rt-PA use.
Other Name: Activase®, Actilyse®

  Hide Detailed Description

Detailed Description:

Stroke remains a major cause of death and disability. Acute thrombolytic therapy offers the potential to achieve early recanalization (reopening of blocked arteries), save tissues, and improve outcome. Currently, intravenous (IV) recombinant tissue plasminogen activator (rt-PA) is the only approved acute stroke therapy. IV rt-PA is an effective therapy for acute ischemic stroke but has substantial limitations when used alone to open blocked arteries The Interventional Management of Stroke (IMS III) Trial is a multi-center study that will compare two different treatment approaches for restoring blood flow to the brain. One approach, giving the clot-dissolving drug rt-PA, is already FDA-approved when given through a vein (IV). This treatment will be compared to a new approach, giving rt-PA at a lower dose first through IV in the arm and then, if a blood clot in the brain artery is found, through a small tube or catheter at the site of the blood clot (intra-arterial or IA) to see which is better. Both approaches must be initiated within three hours of stroke onset.

The primary goal of this trial is to determine if individuals with ischemic stroke treated with rt-PA using an endovascular therapy approach to recanalization started within 3 hours of onset are more likely to have a better outcome than individuals treated with standard IV rt-PA alone. While information on device use was collected, individual device performance was not a primary outcome.

Nine hundred participants with moderate to severe ischemic stroke will be enrolled at more than 50 centers in the United States, Canada, Australia and Europe.

Subjects will be randomized in a 2:1 ratio to receive endovascular therapy or IV only with adjustment for clinical site and NIHSSS strata. If enrolled under Amendment 5 or later both treatment groups will receive the standard approved therapy dose of rt-PA (0.9 mg/kg, 90 mg max) administered intravenously over one hour. The consent process and randomization can take place prior to or anytime up to forty minutes after the IV bolus dose. If, at the 40 minute time point, no consent has been obtained or randomization has not been completed, the patient will no longer be eligible for IMS III enrollment. After consent, the endovascular therapy group will then undergo immediate angiography. If clot is not demonstrated, no more treatment is administered.

If clot is demonstrated, the neurointerventionalist will then choose from currently available but trial defined endovascular therapy approaches, choosing the treatment they feel will be most effective in attempting to reopen the blocked artery. These approaches utilize local regulatory, US FDA and IMS III Executive Committee approved devices for the intra-arterial infusion of investigational rt-PA using standard microcatheter or the EKOS Micro-Infusion Catheter® (in US) or embolectomy devices including the Concentric Retriever Device®, the Penumbra System ™, or the Solitaire™ FR Revascularization Device. All devices must be used per the manufacturer's instructions for use. Endovascular therapy, whether initially with the Merci® Retriever, EKOS Micro-Infusion Catheter, Penumbra System™, Solitaire™, a future device, or infusion of IA rt-PA via a standard microcatheter, must be started within 5 hours and completed within 7 hours of symptom onset. The maximum dose of IA rt-PA is 22mg (maximum 2 to 4 mg bolus and infusion at a rate of 10 mg/hr). Use of tandem devices (i.e. EKOS Micro-Infusion Catheter, Merci Retriever®, Penumbra System™, or Solitaire™) in a single case is a protocol violation. Only standard microcatheter rt-PA infusion therapy may be administered following attempt with a device.

The primary measure of benefit in this trial is the ability of the individual with stroke to live and function independently 3 months after the stroke. This trial will also determine and compare the safety and cost effectiveness of the combined endovascular therapy to the standard IV rt-PA approach.

Duration of the study for participants is approximately 12 months.

  Eligibility

Ages Eligible for Study:   18 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Age: 18 through 82 years (i.e., candidates must have had their 18th birthday, but not had their 83rd birthday)
  • Initiation of intravenous rt-PA within 3 hours of onset of stroke symptoms. Time of onset is defined as the last time when the subject was witnessed to be at baseline (i.e., subjects who have stroke symptoms upon awakening will be considered to have their onset at beginning of sleep)
  • An NIHSSS >/= 10 at the time that intravenous rt-PA is begun or an NIHSSS >7 and <10 with an occlusion seen in M1, ICA or basilar artery on CTA at institutions where baseline CTA imaging is standard of care for acute stroke patients.
  • Investigator verification that the subject has received/ is receiving the correct IV rt-PA dose for the estimated weight prior to randomization

Exclusion Criteria

  • History of stroke in the past 3 months
  • Previous intra-cranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arteriovenous malformation
  • Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT scan is normal
  • Hypertension at time of treatment; systolic BP > 185 or diastolic > 110 mm Hg) or aggressive measures to lower BP to below these limits are needed.
  • Presumed septic embolus, or suspicion of bacterial endocarditis
  • Presumed pericarditis, including pericarditis after acute MI
  • Suspicion of aortic dissection
  • Recent (within 30 days) surgery or biopsy of parenchymal organ
  • Recent (within 30 days) trauma, with internal injuries or ulcerative wounds
  • Recent (within 90 days) severe head trauma or head trauma with loss of consciousness
  • Any active or recent (within 30 days) hemorrhage
  • Pts with known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency or oral anticoagulant therapy require coagulation labs results prior to enrollment. Any subject with INR > 1.7 or institutionally equivalent prothrombin time is excluded. Patients without history or suspicion of coagulopathy do not require INR or prothrombin time lab results to be available prior to enrollment.
  • Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission
  • Baseline lab values: glucose < 50 mg/dl or > 400 mg/dl, platelets <100,000, or Hct <25
  • Requires hemodialysis or peritoneal dialysis, or has a contraindication to an angiogram for whatever reason
  • Received heparin or a direct thrombin inhibitor (Angiomax, argatroban, Refludan, Pradaxa) within 48 hours must have a normal partial thromboplastin time (PTT) to be eligible
  • History of an arterial puncture at a non-compressible site or a lumbar puncture in the previous 7 days
  • History of seizure at onset of stroke
  • History of a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be < 2. This excludes patients who live in a nursing home or who are not fully independent for activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)
  • Other serious, advanced, or terminal illness
  • Any other condition that the investigator feels would pose a significant hazard to the subject if Activase (Alteplase) therapy is initiated
  • Current participation in another research drug treatment protocol
  • Informed consent is not or cannot be obtained.
  • High density lesion consistent with hemorrhage of any degree on baseline imaging
  • Significant mass effect with midline shift on baseline imaging
  • Large (>1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan. (ASPECTS of < 4 can be used as a guideline) Sulcal effacement and/or loss of grey-white differentiation are not contraindications to tx
  • CT evidence of intrapararenchymal tumor
  • Baseline CTA without evidence of arterial occlusion
  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: NCT00359424

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center, 222 W. Thomas Road, Suite 404
Phoenix, Arizona, United States, 85013
Mayo Clinic Arizona, 5777 E. Mayo Blvd.
Scottsdale, Arizona, United States, 85054
United States, California
UCLA Medical Center, 924 Westwood Blvd., Suite 300
Los Angeles, California, United States, 90024
Hoag Memorial Hospital
Newport Beach, California, United States, 92658
Santa Monica-UCLA Medical Center, 1250 16th Street
Santa Monica, California, United States, 90404
United States, Colorado
Colorado Neurological Institute, Swedish Medical Center, 501 E. Hampden Ave.
Englewood, Colorado, United States, 80113-2771
United States, Connecticut
Stroke Center at Hartford, 80 Seymour St. Rm JB603
Hartford, Connecticut, United States, 06102
United States, Florida
Morton Plant Mease Health Care, 300 Pinellas Street MS 49
Clearwater, Florida, United States, 33756
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
United States, Illinois
Alexian Brothers Medical Center, 800 Biesterfield Rd.
Elk Grove Village, Illinois, United States, 60007
United States, Iowa
Ruan Neurological Mercy Medical Center, 1111 6th Ave., Ste. 400
Des Moines, Iowa, United States, 50314
United States, Kentucky
St. Elizabeth Medical Center South, One Medical Village Drive
Edgewood, Kentucky, United States, 41017
St Luke's West Hospital, 7380 Turfway Rd.
Florence, Kentucky, United States, 41042
St. Luke's Hospital East, 85 N. Grand Ave.
Ft. Thomas, Kentucky, United States, 41075
University of Louisville, Kentucky Neuroscience Research, Stroke Research, 401 East Chestnut Street, Suite 520
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins University, 1500 Orleans St. 3M South
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Massachusetts General Hospital, 55 Fruit Street
Boston, Massachusetts, United States, 02114
Lahey Clinic Medical Center
Burlington, Massachusetts, United States, 01805
United States, Michigan
Henry Ford Hospital, 2799 W Grand Blvd, CFP-260
Detroit, Michigan, United States, 48202
Michigan State University, Sparrow Hospital, B 401 Clinical Center
East Lansing, Michigan, United States, 48824
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Washington University/Barnes Jewish Hospital, 660 S. Euclid Avenue
St. Louis, Missouri, United States, 63110
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Suny Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Mission Hospital, 509 Biltmore Avenue
Asheville, North Carolina, United States, 28801
University of North Carolina, CB # 7025, 7003 Neurosciences Hospital, 7th Floor
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
The University Hospital, 234 Goodman Ave.
Cincinnati, Ohio, United States, 45219
The Jewish Hospital of Cincinnati, 4777 East Galbraith Rd
Cincinnati, Ohio, United States, 45236
Good Samaritan Hospital, 375 Dixmyth Ave.
Cincinnati, Ohio, United States, 45220-2489
The Christ Hospital, 2139 Auburn Ave.
Cincinnati, Ohio, United States, 45219
Mercy Hospital, Mt Airy, 2446 Kipling Ave.
Cincinnati, Ohio, United States, 45239
Mercy Hospital Anderson, 7500 State Rd
Cincinnati, Ohio, United States, 45255
Mercy Hospital, Western Hills, 3131 Queen City Ave.
Cincinnati, Ohio, United States, 45238
University Hospitals of Cleveland, Case Western Reserve University,Case Western Neurological Unit, 11100 Euclid Avenue, Lakeside 5508
Cleveland, Ohio, United States, 44106
Riverside Methodist Hospital, 3535 Olentangy River Road
Columbus, Ohio, United States, 43214
Mercy Hospital Fairfield, 3000 Mack Rd.
Fairfield, Ohio, United States, 45014
Bethesda North Hospital, 10500 Montgomery Rd.
Montgomery, Ohio, United States, 45242
United States, Oregon
OHSU, Oregon Stroke Center, Providence St. Vincent's Hospital, Providence Portland Hospital
Portland, Oregon, United States, 97239
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Lehigh Valley Hospital Center, 1200 South Cedar Crest Blvd.
Allentown, Pennsylvania, United States, 18103
PENN State M.S. Hershey Medical Center, 500 University Drive MC: HS 86, Long Lane Rom HG:212
Hershey, Pennsylvania, United States, 17033
Allegheny General Hospital, 420 East North Avenue, East Wing Office Bldg., Suite 206
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh, Medical Center, 200 Lothrop Street, PUH C-400
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
University Medical Center at Brackenridge Hospital
Austin, Texas, United States, 78701
University of Texas Medical School at Houston, 6431 Fannin, MSB 7.044
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Froedtert Hospital, Medical College of Wisconsin, 9200 W. Wisconsin Avenue
Milwaukee, Wisconsin, United States, 53226
Australia
Royal Prince Alfred Hospital, Level 10 King George V Building, Missenden Rd
Camperdown, Australia, NSW 2050
St. Vincent's Hospital, Clincial Trial Centre Level 5, 378 Victoria St., Darlinghurst
Sydney, Australia, NSW 2010
Monash Medical Center, Dept. of Neurology, 246 Clayton Rd, Clayton
Victoria, Australia, 3168
Royal Melbourne Hospital, Dept. of Neurology, 4 East, Grattan St, Parkville
Victoria, Australia, 3050
Canada, Alberta
University of Calgary, Calgary Health Region/Foothills Hospital, 1403 29th Street NW
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
University of British Columbia, Vancouver General Hospital, VGH Stroke Program, Gordon & Leslie Diamond Healthcare Centre, 2775 Laurel St., 8th Fl., Ste. 8295
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
The Ottawa Hospital, Civic Campus, CPC Main, RM 36, Box 608, 1053 Carling Avenue
Ottawa, Ontario, Canada, K1Y 4E9
Toronto Western Hospital, 5th Floor Rm. 447, 399 Bathurst St.
Toronto, Ontario, Canada, M5T 2S8
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Centre Hospital University of Montreal
Montreal, Quebec, Canada, H2L4M1
France
Bichat Stroke Centre
Paris, Cedex, France, 75018
Germany
Technische Universität, Dresden
Dresden, Germany, 01307
University of Freiburg
Freiburg, Germany, 79106
Ernst Moritz Arndt University
Greifswald, Germany, 17475
Martin-Luther University
Halle, Germany, 06120
Asklepios Klinik Nord Heidberg
Hamburg, Germany, 22417
Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands, 3435 CM
Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Spain, 8916
Hospital Vall d´Hebron
Barcelona, Spain, 8035
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Centre Hospitalier, University Vaudois
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Joseph Broderick
Medical University of South Carolina
University of Calgary
Investigators
Principal Investigator: Joseph P. Broderick, MD Primary Neurologist Investigator, University of Cincinnati Academic Health Center
Principal Investigator: Thomas A. Tomsick, MD Primary Interventional Investigator, University of Cincinnati Academic Health Center
  More Information

No publications provided by University of Cincinnati

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joseph Broderick, Professor and Chairman Department of Neurology, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00359424     History of Changes
Other Study ID Numbers: U01NS052220, U01NS052220, U01NS054630, 2009-017454-12
Study First Received: July 31, 2006
Results First Received: July 4, 2013
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ethics Commission
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Ministry of Health
Switzerland: Swissmedic

Keywords provided by University of Cincinnati:
acute ischemic stroke
rt-PA
thrombolytic
recombinant tissue plasminogen activator
recanalization
blood clot
stroke
clot-dissolving
Activase®
Actilyse®
Concentric Merci® Retriever
EKOS® Micro-Infusion catheter (MicroLysus)
The Penumbra System™
Standard microcatheter

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
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 September 18, 2014