: Currently, intravenous tissue plasminogen activator administered within 3 hours of symptom onset is the only FDA-approved treatment for acute ischemic stroke. However, few patients qualify for this therapy, and there is an urgent need to identify alternative treatment strategies that extend the time-window with low hemorrhage risk. Endovascular mechanical embolectomy devices offer this promise. Moreover, the potential to identify an efficacious therapeutic approach may be optimized by employing patient-specific physiologic selection criteria (such as the presence of an MRI-defined ischemic penumbra). The MR RESCUE Trial will determine whether diffusion-perfusion MRI can identify patients who will benefit substantially from mechanical embolectomy, with the Concentric Retriever device for acute ischemic stroke 0-8 hours from onset. This study is a multi-center, randomized, controlled phase 2 trial of endovascular clot retrieval vs. conventional medical care in 120 patients with acute, large-vessel, anterior circulation ischemic stroke, stratified by MRI pattern (penumbral vs. non-penumbral). The primary hypothesis is that the presence of substantial ischemic penumbral tissue on MRI identifies, and the absence of treatment benefit (equivalency) in patients without penumbral regions, pre-treatment. Successful conduct of the trial will determine whether diffusion-perfusion MRI is an appropriate selection criterion for mechanical recanalization therapy for acute ischemic stroke. A positive trial will suggest substantial clinical benefit from embolectomy therapy in the group of patients with a penumbral MRI pattern, and permit informed design of definitive phase 3 trial(s) of endovascular embolectomy. A sub-study will utilize the thrombi extracted at endovascular mechanical embolectomy in trial patients to perform the first systematic anatomic, structural, and biochemical functional studies of platelet content, clot formation, and fibrinolysis in actual stroke-causing human thrombi.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Specialized Center (P50)
Project #
5P50NS044378-03
Application #
7553854
Study Section
Special Emphasis Panel (ZNS1)
Project Start
Project End
Budget Start
2005-06-01
Budget End
2006-05-31
Support Year
3
Fiscal Year
2005
Total Cost
$174,566
Indirect Cost
Name
University of California Los Angeles
Department
Type
DUNS #
092530369
City
Los Angeles
State
CA
Country
United States
Zip Code
90095
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Lou, Xin; Yu, Songlin; Scalzo, Fabien et al. (2017) Multi-delay ASL can identify leptomeningeal collateral perfusion in endovascular therapy of ischemic stroke. Oncotarget 8:2437-2443
Nael, Kambiz; Knitter, James R; Jahan, Reza et al. (2017) Multiparametric Magnetic Resonance Imaging for Prediction of Parenchymal Hemorrhage in Acute Ischemic Stroke After Reperfusion Therapy. Stroke 48:664-670
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Vespa, Paul; Hanley, Daniel; Betz, Joshua et al. (2016) ICES (Intraoperative Stereotactic Computed Tomography-Guided Endoscopic Surgery) for Brain Hemorrhage: A Multicenter Randomized Controlled Trial. Stroke 47:2749-2755
Liu, Dezhi; Scalzo, Fabien; Starkman, Sidney et al. (2015) DWI Lesion Patterns Predict Outcome in Stroke Patients with Thrombolysis. Cerebrovasc Dis 40:279-285
Chaisinanunkul, Napasri; Adeoye, Opeolu; Lewis, Roger J et al. (2015) Adopting a Patient-Centered Approach to Primary Outcome Analysis of Acute Stroke Trials Using a Utility-Weighted Modified Rankin Scale. Stroke 46:2238-43
Guluma, Kama Z; Liebeskind, David S; Raman, Rema et al. (2015) Feasibility and Safety of Using External Counterpulsation to Augment Cerebral Blood Flow in Acute Ischemic Stroke-The Counterpulsation to Upgrade Forward Flow in Stroke (CUFFS) Trial. J Stroke Cerebrovasc Dis 24:2596-604
Shi, Zhong-Song; Duckwiler, Gary R; Jahan, Reza et al. (2015) New Cerebral Microbleeds After Mechanical Thrombectomy for Large-Vessel Occlusion Strokes. Medicine (Baltimore) 94:e2180
Yu, Songlin; Liebeskind, David S; Dua, Sumit et al. (2015) Postischemic hyperperfusion on arterial spin labeled perfusion MRI is linked to hemorrhagic transformation in stroke. J Cereb Blood Flow Metab 35:630-7

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