Clinical trial NCT00389467: Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy
Official title: Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: stroke
ischemic stroke
blood clot
Merci Retriever
Penumbra System
embolectomy
magnetic resonance imaging
MRI
CT
SPOTRIAS
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2006-10-18
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 4.5 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 4.5-hour time window.

Two of the most promising new devices are the Merci Retriever, a tiny corkscrew device, and the Penumbra System, an aspiration device. Both are 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 or Penumbra System within 8 hours of symptom onset to standard medical treatment, and to identify people who might benefit from the devices by the appearance of the stroke on multimodal computerized tomography (CT) or 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, and the Penumbra System is successful in opening up blocked blood vessels in approximately 80% 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 either receive treatment by mechanical embolectomy with the Merci Retriever or Penumbra System and standard medical care or treatment with 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 undergoing the Merci Retriever or Penumbra System procedure will have a cerebral arteriogram with pictures taken with dye prior to the procedure to determine the location of the blockage, and following the procedure to determine if blood supply has been restored. The total mechanical embolectomy procedure with either device 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 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 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)

Exclusion Criteria:

* 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
* Severely compromised liver function
* Current therapy with metformin, aminoglycosides

Primary outcomes:
measure: The Modified Rankin Scale Score
timeFrame: at 90 days post-stroke
Secondary outcomes:
measure: Symptomatic Hemorrhagic Transformation
timeFrame: from baseline to day 7
measure: Day 90 Mortality
timeFrame: at day 90
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California at Los Angeles, UCLA Stroke Network, 924 Westwood Blvd #300
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center 4867 W Sunset Blvd., Los Angeles CA 90027
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center 8700 Beverly Blvd., Los Angeles CA 90048
state: California
city: San Diego
country: United States
facility: University of California at San Diego, UCSD Medical Center, 200 W. Arbor Drive, OPC, 3rd Floor Suite 3
state: California
city: Santa Monica
country: United States
facility: Santa Monica-UCLA Medical Center, 1225 15th Street Santa Monica, CA 90404
state: California
city: Washington
country: United States
facility: Georgetown University, Georgetown University Hospital, Room GG012, Ground Floor Gorman, 3800 Reservoir Road, NW
state: District of Columbia
city: Washington
country: United States
facility: Washington Hospital Center, 110 Irving Street, NW, Washington, DC 20010
state: District of Columbia
city: Miami
country: United States
facility: University of Miami 1400 NW 10th Street, 10th Floor, Miami FL 33136
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics, 200 Hawkins Dr, Iowa City, IA 52242
state: Iowa
city: Bethesda
country: United States
facility: Suburban Hospital, 8600 Old Georgetown Road, Bethesda, MD 20814
state: Maryland
city: Boston
country: United States
facility: Boston University, One Boston Medical Center Place, Department of Neurology, C329
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital, 101 Huntington Ave Ste 300
state: Massachusetts
city: St. Louis
country: United States
facility: St. Louis University Hospital, 3635 Vista Avenue at Grand Boulevard Saint Louis, MO
state: Missouri
city: New York
country: United States
facility: Cornell University, New York Presbyterian Hospital, Cornell Campus, 525 East 68th St, Box 141
state: New York
city: New York
country: United States
facility: Columbia University, 710 W 168th St, NI 551, ,
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati, Department of Neurology, University of Cincinnati Medical Center, 231 Albert Sabin Way, Medical Sciences Bldg, Rm 4015, PO Box 670525
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh, PUHC-426, 200 Lothrop Street
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC 29403
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Center for Neurologic Research
state: Tennessee
city: Houston
country: United States
facility: University of Texas at Houston, University of Texas, Houston Stroke Program, Department of Neurology, 6431 Fannin Street, MSB 7044
state: Texas
city: Morgantown
country: United States
facility: West Virginia University 1 Medical Center, Morgantown WV 26506
state: West Virginia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: Professor of Neurology, Georgetown University
name: Chelsea S Kidwell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Radiology, UCLA Medical Center, Interventional Neuroradiology
name: Reza Jahan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kidwell 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.