Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy
MR RESCUE
2 other identifiers
interventional
127
2 countries
22
Brief Summary
The purpose of this study is to compare the effectiveness of treating acute ischemic stroke with mechanical embolectomy using the Merci Retriever or the Penumbra System within 8 hours of symptom onset to standard medical treatment, and to identify people who might benefit from mechanical embolectomy by the appearance of stroke on multimodal computerized tomography (CT) or magnetic resonance (MR) imaging.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 stroke
Started May 2004
Longer than P75 for phase_2 stroke
22 active sites
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
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 16, 2006
CompletedFirst Posted
Study publicly available on registry
October 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
March 26, 2014
CompletedMarch 26, 2014
February 1, 2014
7.9 years
October 16, 2006
April 12, 2013
February 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Modified Rankin Scale Score
Scale name is provided (Modified Rankin Scale) which is a standard measure of functional neurologic outcome in stroke. The scale runs from 0-6, running from perfect health without symptoms to death. * 0 - No symptoms. * 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. * 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. * 3 - Moderate disability. Requires some help, but able to walk unassisted. * 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. * 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. * 6 - Dead.
at 90 days post-stroke
Secondary Outcomes (2)
Symptomatic Hemorrhagic Transformation
from baseline to day 7
Day 90 Mortality
at day 90
Study Arms (2)
1 Mechanical Embolectomy
ACTIVE COMPARATORParticipants will be randomized to receive mechanical embolectomy treatment either with the Merci Retriever or Penumbra System and standard medical care or treatment with standard medical care alone.
2
NO INTERVENTIONstandard medical care
Interventions
The MERCI (Mechanical Embolus Removal in Cerebral Ischemia) 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 X6, L5, L4, L6, V series, DAC). The Penumbra System uses a reperfusion catheter in parallel with a separator component and an aspiration source to achieve separation of the thrombus and subsequent aspiration of the occlusion from the vessel. The system is available in different sizes according to the target vessels (041 Reperfusion Catheter/Separator pair for use in vessels larger than 3mm, notably the ICA and M1; 032 Reperfusion Catheter/Separator pair for use in vessels 2mm - 3mm, notably the M2).
Eligibility Criteria
You may qualify if:
- 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 or CT 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 0-2
You may not qualify if:
- NIHSS \>/= 30
- Contraindication to MRI (pacemaker etc)
- Acute intracranial hemorrhage
- Coma
- Rapidly improving neurological signs prior to randomization
- Pre-existing medical, neurological or psychiatric disease that would confound the neurological, functional, or imaging evaluations
- Pregnancy
- Known allergy to iodine previously refractory to pretreatment medications
- Current participation in another experimental treatment protocol
- Contrast-Enhanced Neck MRA (magnetic resonance angiography) or CTA (computed tomography angiography) suggests proximal ICA occlusion, proximal carotid stenosis \> 67%, or dissection
- INR \> 3.0 (international normalized ratio)
- PTT \> 3 x Normal (partial thromboplastin time)
- Imaging data cannot be processed by the MR RESCUE computer
- Renal Failure (serum creatinine \> 2.0 or Glomerular Filtration Rate \[GFR\] \< 30)
- Contraindication to MRI (pacemaker, etc)
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
University of California at Los Angeles, UCLA Stroke Network, 924 Westwood Blvd #300
Los Angeles, California, 90024, United States
Kaiser Permanente Los Angeles Medical Center 4867 W Sunset Blvd., Los Angeles CA 90027
Los Angeles, California, 90027, United States
Cedars Sinai Medical Center 8700 Beverly Blvd., Los Angeles CA 90048
Los Angeles, California, 90048, United States
University of California at San Diego, UCSD Medical Center, 200 W. Arbor Drive, OPC, 3rd Floor Suite 3
San Diego, California, 92103, United States
Santa Monica-UCLA Medical Center, 1225 15th Street Santa Monica, CA 90404
Santa Monica, California, 90404, United States
Georgetown University, Georgetown University Hospital, Room GG012, Ground Floor Gorman, 3800 Reservoir Road, NW
Washington D.C., District of Columbia, 20007, United States
Washington Hospital Center, 110 Irving Street, NW, Washington, DC 20010
Washington D.C., District of Columbia, 20010, United States
University of Miami 1400 NW 10th Street, 10th Floor, Miami FL 33136
Miami, Florida, 33136, United States
University of Iowa Hospitals and Clinics, 200 Hawkins Dr, Iowa City, IA 52242
Iowa City, Iowa, 52242, United States
Suburban Hospital, 8600 Old Georgetown Road, Bethesda, MD 20814
Bethesda, Maryland, 20814, United States
Boston University, One Boston Medical Center Place, Department of Neurology, C329
Boston, Massachusetts, 01228, United States
Massachusetts General Hospital, 101 Huntington Ave Ste 300
Boston, Massachusetts, 02199, United States
St. Louis University Hospital, 3635 Vista Avenue at Grand Boulevard Saint Louis, MO
St Louis, Missouri, 63110, United States
Cornell University, New York Presbyterian Hospital, Cornell Campus, 525 East 68th St, Box 141
New York, New York, 10021, United States
Columbia University, 710 W 168th St, NI 551, ,
New York, New York, 10032, United States
University of Cincinnati, Department of Neurology, University of Cincinnati Medical Center, 231 Albert Sabin Way, Medical Sciences Bldg, Rm 4015, PO Box 670525
Cincinnati, Ohio, 45267, United States
University of Pittsburgh, PUHC-426, 200 Lothrop Street
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC 29403
Charleston, South Carolina, 29403, United States
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, United States
University of Texas at Houston, University of Texas, Houston Stroke Program, Department of Neurology, 6431 Fannin Street, MSB 7044
Houston, Texas, 77030, United States
West Virginia University 1 Medical Center, Morgantown WV 26506
Morgantown, West Virginia, 26506, United States
University of Calgary
Calgary, Alberta, Canada
Related Publications (2)
Nael K, Knitter JR, Jahan R, Gornbein J, Ajani Z, Feng L, Meyer BC, Schwamm LH, Yoo AJ, Marshall RS, Meyers PM, Yavagal DR, Wintermark M, Liebeskind DS, Guzy J, Starkman S, Saver JL, Kidwell CS. Multiparametric Magnetic Resonance Imaging for Prediction of Parenchymal Hemorrhage in Acute Ischemic Stroke After Reperfusion Therapy. Stroke. 2017 Mar;48(3):664-670. doi: 10.1161/STROKEAHA.116.014343. Epub 2017 Jan 30.
PMID: 28138001DERIVEDKidwell CS, Jahan R, Gornbein J, Alger JR, Nenov V, Ajani Z, Feng L, Meyer BC, Olson S, Schwamm LH, Yoo AJ, Marshall RS, Meyers PM, Yavagal DR, Wintermark M, Guzy J, Starkman S, Saver JL; MR RESCUE Investigators. A trial of imaging selection and endovascular treatment for ischemic stroke. N Engl J Med. 2013 Mar 7;368(10):914-23. doi: 10.1056/NEJMoa1212793. Epub 2013 Feb 8.
PMID: 23394476DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chelsea S. Kidwell, MD
- Organization
- Georgetown University
Study Officials
- PRINCIPAL INVESTIGATOR
Chelsea S Kidwell, MD
Professor of Neurology, Georgetown University
- PRINCIPAL INVESTIGATOR
Reza Jahan, MD
Associate Professor of Radiology, UCLA Medical Center, Interventional Neuroradiology
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology
Study Record Dates
First Submitted
October 16, 2006
First Posted
October 18, 2006
Study Start
May 1, 2004
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
March 26, 2014
Results First Posted
March 26, 2014
Record last verified: 2014-02