Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy

Completed · Phase 2

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT00389467

Run by

University of California, Los Angeles

People needed

127

Starts

2004-05-01

Expected to finish

2012-04-01

Last updated by the study team

2014-03-26

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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
• Allowed but not required: patients treated with IV tPA (tissue plasminogen activator) up to 4.5 hours from symptom onset with persistent target occlusion on post-treatment MR RESCUE MR or CT protocol performed at the completion of drug infusion (Note: Rapidly improving neurological signs prior to randomization is an exclusion)

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)
• MRI Exclusion Criteria:
• Contraindication to MRI (pacemaker, etc)
• CT Exclusion Criteria:
• Contraindication to iodinated contrast**
• *Examples of possible iodinated contrast contraindications include:
• Hyperthyroidism
• History of severe allergic reaction to iodinated contrast material
• History of sever kidney disease as an adult, including tumor or transplant surgery, or family history of kidney failure
• Paraproteinemia syndromes or multiple myeloma
• Collagen vascular disease
• Severe cardiac insufficiency

Where it is running

• University of California at Los Angeles, UCLA Stroke Network, 924 Westwood Blvd #300 — Los Angeles, California, United States
• Kaiser Permanente Los Angeles Medical Center 4867 W Sunset Blvd., Los Angeles CA 90027 — Los Angeles, California, United States
• Cedars Sinai Medical Center 8700 Beverly Blvd., Los Angeles CA 90048 — Los Angeles, California, United States
• University of California at San Diego, UCSD Medical Center, 200 W. Arbor Drive, OPC, 3rd Floor Suite 3 — San Diego, California, United States
• Santa Monica-UCLA Medical Center, 1225 15th Street Santa Monica, CA 90404 — Santa Monica, California, United States
• Georgetown University, Georgetown University Hospital, Room GG012, Ground Floor Gorman, 3800 Reservoir Road, NW — Washington D.C., District of Columbia, United States
• Washington Hospital Center, 110 Irving Street, NW, Washington, DC 20010 — Washington D.C., District of Columbia, United States
• University of Miami 1400 NW 10th Street, 10th Floor, Miami FL 33136 — Miami, Florida, United States
• University of Iowa Hospitals and Clinics, 200 Hawkins Dr, Iowa City, IA 52242 — Iowa City, Iowa, United States
• Suburban Hospital, 8600 Old Georgetown Road, Bethesda, MD 20814 — Bethesda, Maryland, United States
• Boston University, One Boston Medical Center Place, Department of Neurology, C329 — Boston, Massachusetts, United States
• Massachusetts General Hospital, 101 Huntington Ave Ste 300 — Boston, Massachusetts, United States
• St. Louis University Hospital, 3635 Vista Avenue at Grand Boulevard Saint Louis, MO — St Louis, Missouri, United States
• Cornell University, New York Presbyterian Hospital, Cornell Campus, 525 East 68th St, Box 141 — New York, New York, United States
• Columbia University, 710 W 168th St, NI 551, , — New York, New York, 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, United States
• University of Pittsburgh, PUHC-426, 200 Lothrop Street — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC 29403 — Charleston, South Carolina, 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, United States
• West Virginia University 1 Medical Center, Morgantown WV 26506 — Morgantown, West Virginia, United States
• University of Calgary — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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