Published online before print October 28, 2004, doi: 10.1161/01.STR.0000147718.12954.60
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(Stroke. 2004;35:2848.)
© 2004 American Heart Association, Inc.
Original Contributions |
MERCI 1
A Phase 1 Study of Mechanical Embolus Removal in Cerebral Ischemia
From the Division of Interventional Neuroradiology (Y.P.G.), Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY; the UCLA Stroke Study Network (S.S.), UCLA Fellowship in Stroke and Cerebrovascular Disorders, UCLA Emergency Medicine Center, Los Angeles, Calif; the Division of Interventional Neuroradiology (G.R.D.), Department of Radiological Sciences, University of California Los Angeles; Neurointerventional Surgery (T.G.), Saint Luke’s Hospital, Department of Radiology, Kansas City, Mo; the UCLA Stroke Unit and Comprehensive Stroke and Vascular Neurology Program (C.S.K.), Department of Neurology, UCLA School of Medicine, Reed Neurological Research Center, Los Angeles, Calif; the Division of Interventional Neuroradiology (R.J.), Department of Radiological Sciences, University of California Los Angeles; the Department of Radiology, Neurosurgery, and Neurology (J.P.-S.), Columbia University, Milstein Hospital, New York, NY; the Department of Neurology (A.S.), Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY; the Department of Radiological Sciences (F.V.), UCLA Medical Center, Los Angeles, Calif; the UCLA Stroke Unit and Comprehensive Stroke and Vascular Neurology Program (J.L.S.), Department of Neurology, UCLA School of Medicine, Los Angeles, Calif.
Correspondence to Dr Y. Pierre Gobin, 525 East 68th Street, Box 141, New York Presbyterian Hospital, New York, NY 10021. E-mail yvg2001{at}med.cornell.edu
Background and Purpose— To report the result of the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) 1 study, a phase 1 trial to evaluate the safety and efficacy of mechanical embolectomy in the cerebral vasculature.
Methods— MERCI 1 enrolled 30 patients in 7 US centers. Main inclusion criteria were: National Institutes of Health Stroke Scale score (NIHSS) 
10; treatment performed within 8 hours from symptoms onset and contra-indication to intravenous thrombolysis; no large hypodensity on computed tomography; and occlusion of a major cerebral artery on the angiogram. Safety was defined by the absence of vascular injury or symptomatic intracranial hemorrhage. Efficacy was assessed by recanalization rate and clinical outcome at 1 month. Significant recovery was defined as 30-day modified Rankin of 0 to 2 in patients with baseline NIHSS 10 to 20 and 30-day modified Rankin of 0 to 3 in patients with baseline NIHSS >20. The procedures were performed with the Merci Retrieval System, a system specially designed for intracranial embolectomy.
Results— Twenty-eight patients were treated. Median NIHSS was 22. Median time from onset to completion of treatment was 6 hours and 15 minutes. Successful recanalization with mechanical embolectomy only was achieved in 12 (43%) patients, and with additional intra-arterial tissue plasminogen activator in 18 (64%) patients. There was one procedure related technical complication, with no clinical consequence. Twelve asymptomatic and no symptomatic intracranial hemorrhages occurred. At 1 month, 9 of 8 revascularized patients and 0 of 10 nonrevascularized patients had achieved significant recovery.
Conclusion— This phase 1 study shows that cerebral embolectomy with the Merci Retriever was safe and that successful recanalization could benefit a significant number of patients, even when performed in an extended 8-hour time window.
Key Words: embolectomy • stroke, ischemic • thrombectomy • thrombolytic therapy
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