Multi MERCI (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™]) (Multi-MERCI)
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|ClinicalTrials.gov Identifier: NCT00318071|
Recruitment Status : Completed
First Posted : April 26, 2006
Last Update Posted : November 7, 2014
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)
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Device: Merci Retriever||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||164 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multinational Controlled Registry to Evaluate the Concentric Merci Retriever System (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318071
|Principal Investigator:||Wade S Smith, MD, PhD||University of California, San Francisco|