Background and Purpose -To report the result of the Mechanical Embolus Remo val in Cerebral Ischemia (MERCI) 1 study, a phase 1 trial to evaluate the safety and efficacy of mechanical embolectomy in the cerebral vascu...Background and Purpose -To report the result of the Mechanical Embolus Remo val 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: Nati onal Institutes of Health Stroke Scale score (NIHSS) ≥ 10; treatment performed within 8 hours from symptoms onset and contra-indication to intravenous thromb olysis; no large hypodensity on computed tomography; and occlusion of a major ce rebral 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 wa s 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 spe cially designed for intracranial embolectomy. Results -Twenty-eight patients were treated. Median NIHSS was 22. Median time from onset to completion of trea tment was 6 hours and 15 minutes. Successful recanalization with mechanical embo lectomy only was achieved in 12 (43% ) patients, and with additional intra-ar terial tissue plasminogen activator in 18 (64% ) patients. There was one proced ure related technical complication, with no clinical consequence. Twelve asympto matic and no symptomatic intracranial hemorrhages occurred. At 1 month, 9 of 8 r evascularized patients and 0 of 10 nonrevascularized patients had achieved signi ficant recovery. Conclusion -This phase 1 study shows that cerebral embolectom y with the Merci Retriever was safe and that successful recanalization could ben efit a significant number of patients, even when performed in an extended 8-ho ur time window.展开更多
文摘Background and Purpose -To report the result of the Mechanical Embolus Remo val 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: Nati onal Institutes of Health Stroke Scale score (NIHSS) ≥ 10; treatment performed within 8 hours from symptoms onset and contra-indication to intravenous thromb olysis; no large hypodensity on computed tomography; and occlusion of a major ce rebral 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 wa s 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 spe cially designed for intracranial embolectomy. Results -Twenty-eight patients were treated. Median NIHSS was 22. Median time from onset to completion of trea tment was 6 hours and 15 minutes. Successful recanalization with mechanical embo lectomy only was achieved in 12 (43% ) patients, and with additional intra-ar terial tissue plasminogen activator in 18 (64% ) patients. There was one proced ure related technical complication, with no clinical consequence. Twelve asympto matic and no symptomatic intracranial hemorrhages occurred. At 1 month, 9 of 8 r evascularized patients and 0 of 10 nonrevascularized patients had achieved signi ficant recovery. Conclusion -This phase 1 study shows that cerebral embolectom y with the Merci Retriever was safe and that successful recanalization could ben efit a significant number of patients, even when performed in an extended 8-ho ur time window.
