MERCI 1: A phase 1 study of mechanical embolus removal in cerebral ischemia

Y. Pierre Gobin, Sidney Starkman, Gary R. Duckwiler, Thomas Grobelny, Chelsea S. Kidwell, Reza Jahan, John Pile-Spellman, Alan Segal, Fernando Vinuela, Jeffrey L. Saver

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371 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2848-2853
Number of pages6
JournalStroke
Volume35
Issue number12
DOIs
StatePublished - Dec 1 2004
Externally publishedYes

Keywords

  • Embolectomy
  • Stroke, ischemic
  • Thrombectomy
  • Thrombolytic therapy

ASJC Scopus subject areas

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

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    Gobin, Y. P., Starkman, S., Duckwiler, G. R., Grobelny, T., Kidwell, C. S., Jahan, R., Pile-Spellman, J., Segal, A., Vinuela, F., & Saver, J. L. (2004). MERCI 1: A phase 1 study of mechanical embolus removal in cerebral ischemia. Stroke, 35(12), 2848-2853. https://doi.org/10.1161/01.STR.0000147718.12954.60