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MR and Recanalization of Stroke Clots Using Embolectomy (MR RESCUE)

This study is currently recruiting participants.
Verified by National Institute of Neurological Disorders and Stroke (NINDS), June 2008

Sponsors and Collaborators: Georgetown University
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00389467
  Purpose

The purpose of this study is to compare the effectiveness of treating acute ischemic stroke with the Merci Retriever (mechanical embolectomy) within 8 hours of symptom onset to standard medical treatment, and to identify people who might benefit from the Merci device by the appearance of the stroke on MRI.


Condition Intervention Phase
Stroke
Procedure: Merci Retriever
Phase II

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:   Magnetic Resonance and Recanalization of Stroke Clots Using Embolectomy

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:
  • The modified Rankin Scale score [ Time Frame: at 90 days post-stroke ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median change in NIH Stroke Scale score, Global test statistic at day 90, hemorrhagic transformation at day 7, serious adverse events, day 90 mortality. [ Time Frame: at day 90 ] [ Designated as safety issue: No ]

Estimated Enrollment:   120
Study Start Date:   May 2004
Estimated Study Completion Date:   May 2009
Estimated Primary Completion Date:   May 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
Participants will be randomized to receive treatment either with the Merci Retriever and standard medical care or standard medical care alone.
Procedure: Merci Retriever
The MERCI Retriever consists of a flexible, nickel titanium (nitinol) wire with a helical-shaped distal tip. The helical distal tip is covered with a platinum radiopaque coil, which facilitates fluoroscopic visualization. The body of the MERCI Retriever is covered with a hydrophilic coating that helps facilitate device placement. The MERCI Retriever is available in 6 configurations (Merci Retrievers X5, X6, L5, L4, L6, Retriever K Mini).
2: No Intervention
standard medical care

Detailed Description:

Stroke most commonly occurs when there is a blockage of blood flow to one of the arteries in the brain. The blockage is often caused by a clot. There is currently only one FDA-approved stroke treatment. However, only 2 percent of ischemic stroke patients receive this treatment because it must be given within 3 hours of the stroke onset. There is an overwhelming need for new treatments that extend the time window to treatment since most individuals with stroke arrive at the hospital after the 3-hour time window.

One of the most promising new devices is the Merci Retriever, a tiny corkscrew device designed to remove clots from arteries and thereby restore blood flow to the brain.

The primary purpose of this study is to compare the effectiveness of treatment with the Merci Retriever within 8 hours of symptom onset to standard medical treatment, and to identify people who might benefit from the device by the appearance of the stroke on magnetic resonance imaging (MRI). Previous testing has determined that the use of the Merci Retriever is successful in opening up blocked blood vessels in approximately ½ of the individuals in whom it is used.

A total of 120 participants from approximately 30 different medical centers will be enrolled into this study. Participants will be randomized to receive treatment either with the Merci Retriever and standard medical care or standard medical care alone. Standard care for stroke patients may include intravenous fluid, careful regulation of blood pressure, blood-thinning medicine (such as heparin or warfarin), anti-platelet medicine (such as aspirin or clopidogrel), and rehabilitation therapies.

Participants receiving the Merci Retriever will have 2 cerebral arteriograms——one prior to the procedure to determine the location of the blockage, and another following the procedure to determine if blood supply has been restored. The total Merci Retriever procedure will take approximately 1 to 2 hours. Participants will have brief neurological exams several times during this time to monitor changes in their neurological condition.

Participants will have follow-up visits, including neurological exams, at 30 days and at 90 days.

This study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit stroke patients by treating more patients in less than 2 hours, and finding ways to treat additional patients later.

  Eligibility
Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • New focal disabling neurologic deficit consistent with acute cerebral ischemia (NIHSS >/= 6)
  • Age >/= 18 ≤ 85
  • Clot retrieval procedure can be initiated within 8 hours from onset
  • Large vessel proximal anterior circulation occlusion on MR angiography (internal carotid, M1 or M2 MCA)
  • Pretreatment MRI performed according to MR RESCUE protocol
  • Signed informed consent obtained from the patient or patient's legally authorized representative
  • Premorbid modified Rankin score of 0-1

Exclusion Criteria:

  • NIHSS >/= 30
  • Contraindication to MRI (pacemaker etc)
  • Acute intracranial hemorrhage
  • Coma
  • Rapidly improving neurological signs prior to randomization
  • Patient meets Health Canada and FDA approved criteria for intravenous t-PA (these patients will receive conventional IV t-PA treatment)
  • Pre-existing medical, neurological or psychiatric disease that would confound the neurological, functional, or imaging evaluations
  • Pregnancy
  • Renal Failure (serum Creatinine > 2.0) unless patient is dialysis dependent
  • Known allergy to iodine previously refractory to pretreatment medications
  • Current participation in another experimental treatment protocol
  • Contrast-Enhanced Neck MRA suggests proximal ICA occlusion, proximal carotid stenosis > 67%, or dissection
  • INR > 3.0
  • PTT > 3 x Normal
  • Diffusion-perfusion data cannot be processed by the MR RESCUE computer
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389467

Contacts
Contact: Judy Guzy, RN     310-794-0600    

Locations
United States, California
University of California at Los Angeles, UCLA Stroke Network, 924 Westwood Blvd #300     Recruiting
      Los Angeles, California, United States, 90024
      Contact: Judy Guzy     310-794-0600        
University of California at San Diego, UCSD Medical Center, 200 W. Arbor Drive, OPC, 3rd Floor Suite 3     Recruiting
      San Diego, California, United States, 92103
      Contact: Janet Werner     619-471-0333        
United States, District of Columbia
Georgetown University, Georgetown University Hospital, Room GG012, Ground Floor Gorman, 3800 Reservoir Road, NW     Recruiting
      Washington, District of Columbia, United States, 20007
      Contact: Bryan Walker     202-444-9796        
Washington Hospital Center, East Building Room 6126, 110 Irving Street, NW     Recruiting
      Washington, District of Columbia, United States, 20010
      Contact: George Chang     202-877-2093        
United States, Maryland
Suburban Hospital, NINDS Section on Stroke Diagnostics and Therapeutics, 10 Center Drive, Room B1D733     Recruiting
      Bethesda, Maryland, United States, 20892
      Contact: Lisa Davis     301-435-7659        
United States, New York
Albany Medical Center, Albany Medical College, MC-70, 47 New Scotland Ave     Recruiting
      Albany, New York, United States, 12208
      Contact: Linda Graca     518-262-5868        
Columbia University, 710 W 168th St, NI 551, ,     Recruiting
      New York, New York, United States, 10032
      Contact: Juan Rivolta     212-342-1491        
Cornell University, New York Presbyterian Hospital, Cornell Campus, 525 East 68th St, Box 141     Recruiting
      New York, New York, United States, 10021
      Contact: Kim Salvaggio     212-746-4998        
United States, Ohio
University of Cincinnati, Department of Neurology, University of Cincinnati Medical Center, 231 Albert Sabin Way, Medical Sciences Bldg, Rm 4015, PO Box 670525     Recruiting
      Cincinnati, Ohio, United States, 45267
      Contact: Janice Carrozzella     513-475-8793        
United States, Pennsylvania
Allegheny Singer Research Institute, 320 East North Avenue     Recruiting
      Pittsburgh, Pennsylvania, United States, 15212
      Contact: Tibetha Santucci     412-647-1618        
University of Pittsburgh, PUHC-426, 200 Lothrop Street     Recruiting
      Pittsburgh, Pennsylvania, United States, 15213
      Contact: Tibetha Santucci     412-647-1618        
United States, Tennessee
Chattanooga Center for Neurologic Research, 721 Glenwood Drive, 467 West     Recruiting
      Chattanooga, Tennessee, United States, 37404
      Contact: Tammi Owen     426-648-0304        
United States, Texas
University of Texas at Houston, University of Texas, Houston Stroke Program, Department of Neurology, 6431 Fannin Street, MSB 7044     Recruiting
      Houston, Texas, United States, 77030
      Contact: Mary Jane Hess     713-500-7078        
United States, Virginia
Inova Fairfax Hospital, Inova Research Center, Fairfax Hospital, 3300 Gallows Road     Recruiting
      Falls Church, Virginia, United States, 22042
      Contact: Barbara Mancini     703-776-2692        
Canada, Alberta
University of Calgary, Foothills Medical Centre, Clinical Trials Stroke Research, Rm C1241B, 1403 29th Street NW     Recruiting
      Calgary, Alberta, Canada, T2N2T9
      Contact: Karyn Fischer            

Sponsors and Collaborators

Investigators
Principal Investigator:     Chelsea S Kidwell, MD     Associate Professor of Neurology, Georgetown University    
Principal Investigator:     Reza Jahan, MD     Associate Professor of Radiology, UCLA Medical Center, Interventional Neuroradiology    
  More Information


Responsible Party:   Georgetown University ( Chelsea S. Kidwell, MD, Associate Professor of Neurology )
Study ID Numbers:   P50NS44378
First Received:   October 16, 2006
Last Updated:   June 2, 2008
ClinicalTrials.gov Identifier:   NCT00389467
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
stroke  
ischemic stroke  
blood clot  
Merci Retriever  
embolectomy
magnetic resonance imaging
MRI
SPOTRIAS

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases
Brain Infarction
Ischemia
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 07, 2008




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