Status:
COMPLETED
Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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...
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 treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00389467
Start Date
May 1 2004
End Date
April 1 2012
Last Update
March 26 2014
Active Locations (22)
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1
University of California at Los Angeles, UCLA Stroke Network, 924 Westwood Blvd #300
Los Angeles, California, United States, 90024
2
Kaiser Permanente Los Angeles Medical Center 4867 W Sunset Blvd., Los Angeles CA 90027
Los Angeles, California, United States, 90027
3
Cedars Sinai Medical Center 8700 Beverly Blvd., Los Angeles CA 90048
Los Angeles, California, United States, 90048
4
University of California at San Diego, UCSD Medical Center, 200 W. Arbor Drive, OPC, 3rd Floor Suite 3
San Diego, California, United States, 92103