Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy - Full Text View

Sponsor:	University of California, Los Angeles
Collaborator:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00389467

Purpose

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.

Condition	Intervention	Phase
Stroke	Device: Merci Retriever and Penumbra System	Phase II

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

Further study details as provided by University of California, Los Angeles:

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 [ Time Frame: at day 90 ] [ Designated as safety issue: No ]
Global test statistic [ Time Frame: at day 90 ] [ Designated as safety issue: No ]
Hemorrhagic transformation [ Time Frame: at day 7 ] [ Designated as safety issue: No ]
Serious adverse events [ Time Frame: at day 90 ] [ Designated as safety issue: No ]
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 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Mechanical Embolectomy: Active Comparator Participants 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.	Device: Merci Retriever and Penumbra System 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 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).
2: No Intervention standard medical care

Arms

Assigned Interventions

1 Mechanical Embolectomy: Active Comparator

Participants 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.

Device: Merci Retriever and Penumbra System

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 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).

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 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

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 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 0-1
Allowed but not required: patients treated with IV tPA 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 or CTA suggests proximal ICA occlusion, proximal carotid stenosis > 67%, or dissection
INR > 3.0
PTT > 3 x Normal
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

Contacts and Locations

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

Contacts

Contact: Judy Guzy, RN

310-794-0600

Show 26 Study Locations

Sponsors and Collaborators

University of California, Los Angeles

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

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

More Information

No publications provided

Responsible Party:	Georgetown University ( Chelsea S. Kidwell, MD, Professor of Neurology )
Study ID Numbers:	P50NS44378, NCT00389467
Study First Received:	October 16, 2006
Last Updated:	November 3, 2009
ClinicalTrials.gov Identifier:	NCT00389467 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

stroke
ischemic stroke
blood clot
Merci Retriever
Penumbra System

embolectomy
magnetic resonance imaging
MRI
CT
SPOTRIAS

Additional relevant MeSH terms:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Brain Ischemia

Central Nervous System Diseases
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on November 30, 2009