Multi MERCI (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™]) (Multi-MERCI)
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)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multinational Controlled Registry to Evaluate the Concentric Merci Retriever System (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])|
- Revascularization success; Rates of device-related serious adverse events [ Time Frame: post-procedure ] [ Designated as safety issue: Yes ]
- modified Rankin scores [ Time Frame: 90-day ] [ Designated as safety issue: No ]
- mortality [ Time Frame: 90-day ] [ Designated as safety issue: Yes ]
- Symptomatic hemorrhage rate [ Time Frame: 24 hour post procedure ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2004|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Treatment arm patients had at least one Merci Retriever deployed
Device: Merci Retriever
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318071
|Principal Investigator:||Wade S Smith, MD, PhD||University of California, San Francisco|