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History of Changes for Study: NCT00389467
MR and Recanalization of Stroke Clots Using Embolectomy (MR RESCUE)
Latest version (submitted February 26, 2014) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 16, 2006 None (earliest Version on record)
2 April 19, 2007 Study Status and Study Description
3 October 12, 2007 Contacts/Locations, Study Status, Eligibility, Study Design and Study Description
4 December 26, 2007 Sponsor/Collaborators, Study Status, Outcome Measures, Arms and Interventions, Study Identification, Contacts/Locations and Study Design
5 June 2, 2008 Study Status and Oversight
6 December 5, 2008 Contacts/Locations, Sponsor/Collaborators, Study Status, Eligibility and Study Description
7 March 30, 2009 Study Status
8 May 12, 2009 Contacts/Locations, Sponsor/Collaborators, Study Status, Study Identification, Outcome Measures, Arms and Interventions, Eligibility and Study Description
9 November 3, 2009 Contacts/Locations, Arms and Interventions, Study Identification, Study Description, Study Status, Eligibility and Conditions
10 June 23, 2010 Contacts/Locations and Study Status
11 January 10, 2012 Recruitment Status, Contacts/Locations, Sponsor/Collaborators, Study Status and Eligibility
12 December 6, 2012 Recruitment Status, Study Status and Study Design
13 February 26, 2014 Outcome Measures, Study Status, Results, Eligibility and Arms and Interventions
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Study NCT00389467
Submitted Date:  October 16, 2006 (v1)

Open or close this module Study Identification
Unique Protocol ID: P50NS044378
Brief Title: MR and Recanalization of Stroke Clots Using Embolectomy (MR RESCUE)
Official Title: Magnetic Resonance and Recanalization of Stroke Clots Using Embolectomy
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2006
Overall Status: Recruiting
Study Start: May 2004
Primary Completion:
Study Completion:
First Submitted: October 16, 2006
First Submitted that
Met QC Criteria:
October 16, 2006
First Posted: October 18, 2006 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 16, 2006
Last Update Posted: October 18, 2006 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: 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.
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 20 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.

Open or close this module Conditions
Conditions: Stroke
Keywords: stroke
ischemic stroke
blood clot
Merci Retriever
embolectomy
magnetic resonance imaging
MRI
SPOTRIAS
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Single (masked role unspecified)
Allocation: Randomized
Enrollment: 120
Open or close this module Arms and Interventions
Intervention Details:
Procedure: Merci Retriever
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The modified Rankin Scale score at 90 days post-stroke
Secondary Outcome Measures:
1. Median change in NIH Stroke Scale score, Global test statistic at day 90, hemorrhagic transformation at day 7, serious adverse events, day 90 mortality.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 85 Years
Sex: All
Gender Based:
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
  • 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
Open or close this module Contacts/Locations
Central Contact Person: Judy Guzy, RN
Telephone: 310-794-0600
Study Officials: Chelsea S Kidwell, MD
Principal Investigator
Associate Professor of Neurology, Georgetown University
Reza Jahan, MD
Principal Investigator
Associate Professor of Radiology, UCLA Medical Center, Interventional Neuroradiology
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: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:Contact: Nancy Kelly 619-543-7764
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:Contact: Susan Sutton 202-444-7753
Washington Hospital Center, East Building Room 6126, 110 Irving Street, NW
[Recruiting]
Washington, District of Columbia, United States, 20010
Contact: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:Contact: Lisa Davis 301-435-2269
United States, New York
Albany Medical Center, Albany Medical College, MC-70, 47 New Scotland Ave
[Recruiting]
Albany, New York, United States, 12208
Contact:Contact: Linda Graca 518-262-5868
Cornell University, New York Presbyterian Hospital, Cornell Campus, 525 East 68th St, Box 141
[Recruiting]
New York, New York, United States, 10021
Contact:Contact: Kim Scott 212-746-6653
Columbia University, 710 W 168th St, NI 551, ,
[Recruiting]
New York, New York, United States, 10032
Contact:Contact: Juan Rivolta 212-342-1491
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:Contact: Jeanne Draggoo 513-558-2869
Case Western Reserve University, University Hospitals of Cleveland, 11100 Euclid Avenue
[Recruiting]
Cleveland, Ohio, United States, 44106
Contact:Contact: Christopher Murphy 216-983-0796
United States, Pennsylvania
Allegheny Singer Research Institute, 320 East North Avenue
[Recruiting]
Pittsburgh, Pennsylvania, United States, 15212
Contact:Contact: Andrea Erfort 412-359-3721
University of Pittsburgh, PUHC-426, 200 Lothrop Street
[Recruiting]
Pittsburgh, Pennsylvania, United States, 15213
Contact:Contact: Tibetha Santucc 412-647-3639
United States, Tennessee
Chattanooga Center for Neurologic Research, 721 Glenwood Drive, 467 West
[Recruiting]
Chattanooga, Tennessee, United States, 37404
Contact: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:Contact: Nichole Porche 713-500-7084
United States, Virginia
Inova Fairfax Hospital, Inova Research Center, Fairfax Hospital, 3300 Gallows Road
[Recruiting]
Falls Church, Virginia, United States, 22042
Contact:Contact: Christiana Jackai 703-776-4131
Canada, Alberta
University of Calgary, Foothills Medical Centre, Clinical Trials Stroke Research, Rm C1241B, 1403 29th Street NW
[Recruiting]
Calgary, Alberta, Canada, T2N2T9
Contact:Contact: Karyn Fischer
University of Alberta - Edmonton, 1800 College Plaza, 8215-112 Street
[Recruiting]
Edmonton, Alberta, Canada, T6G2C8
Contact:Contact: Brenda Schwindt 780-407-7740
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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