The primary objectives of the Multi MERCI trial were: * to evaluate the addition of the Merci L5 Retriever * additionally permit use of the Merci Retrieval System in the setting of persistent clot following IV t-PA treatment (use in the 0-8 hour window for patients ineligible for IV t-PA was also permitted)
Per the Multi MERCI protocol, up to 230 patients could be treated at up to 30 centers. The intended trial indication for the Merci L5 Retriever was to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients that were contraindicated or failed treatment with intravenous t-PA were allowed to be enrolled under the Multi MERCI protocol. Per the Multi MERCI protocol, following inclusion of the Merci L5 Retriever the operating physician was required to initiate treatment with the Merci L5 Retriever. At the physician's discretion, subsequent passes could be made with the Merci L5 Retriever, Merci X6 Retriever and/or Merci X5 Retriever. Adverse events were adjudicated by an independent Data Safety and Monitoring Board (Capital DSMB).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
164
For patients eligible to participate in the trial, the operating physician initiated treatment with the Merci L5 Retriever to remove large vessel thrombotic occlusion and recanalization of the vessel. Subsequent treatment could be made with Merci X6 or X5 Merci Retrievers. Large vessel arteries are defined as internal carotid, middle cerebral M1/M2 segments, basilar, and vertebral arteries. Recanalization was defined as TIMI II or TIMI III per angiography.
Revascularization success; Rates of device-related serious adverse events
Time frame: post-procedure
modified Rankin scores
Time frame: 90-day
mortality
Time frame: 90-day
Symptomatic hemorrhage rate
Time frame: 24 hour post procedure
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