MERCI
Safety and Efficacy of Mechanical Embolectomy in Acute Ischemic Stroke
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Status:
Trial complete. Results published in April 2005.
Purpose:
To evaluate the safety and efficacy of a mechanical embolectomy device (Merci Retriever) in opening occluded vessels in stroke patients.
Interventions:
Mechanical Thrombectomy
Extraction of cerebral emboli by using a novel retriever, mircocatheter and balloon guide catheter system.
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Year Started:
2001
Year Finished:
2003
Design:
Multicenter, non-randomized, phase II trial.
Inclusion Criteria
Patients with acute ischemic stroke symptoms (NIHSS score > or = 8) who present within 3 hours of stroke onset and are not iv-tPA eligible,or who can be treated within 8 hours of symptom onset, with treatable vessels. Treatable vessels were defined as intracravial vertebral artery, basilar artery, intracranial carotis artery (ICA), ICA terminal bifurcation, or the middle cerebral artery (MCA) first division (M1).
Exclusion Criteria
Hemorrhage, stroke symptoms within 3 hours of onset and iv-tPA eligible, stroke symptoms beyond 8 hours from onset.
Patient Involvement:
Enrolled patients underwent the mechanical embolectomy procedure using the balloon catheter and retrieval system. Follow-up assessments were performed at 24 hours, 5 days, 30 days, and 90 days.
Primary Outcome:
Degree of arterial recanalization (assessed with TIMI grading with a benchmark of 18% for spontaneous recanalization rate, the rate from the ProAct 2 controls group); incidence of major complications.
Secondary Outcome:
Clinical outcomes, as defined by the MRS and NIHSS scores at 30 and 90 days, and the combined events of myocardial infarction, second stroke, and death within 30 days. Good neurological outcome was defined as MRS of < or = 2, or NIHSS score improvement of 10 points or more.
Results:
Recanalization (TIMI 2 & 3) of treatable vessels with the study device was acheived in 48% (p<0.0001, as compared to the 18% spontaneous rate reported in ProAct 2) 68 of the 141 patients treated in trial 1 and 2. Postprocedure TIMI scores of treatable vessels were TIMI 2 and 3 (24%), TIMI 1 (18%), and TIMI 0 (33%). Investigators used adjuvant therapy in 51 instances after deployment of the device. Clinically significant procedural complications occurred in 10 of 141 (7%) patients, and 11 of the 341 (3%) devices used during the trial fractured, likely causing the death of 2 patients.
Source of Information:
Stroke. 2005 Jul;36(7):1432-8.
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This information last updated on: 8/14/2008
Reviewed on: 08/14/2008.
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