NCT00318071

Multi MERCI (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])

A Multinational Controlled Registry to Evaluate the Concentric Merci Retriever System (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Stryker Neurovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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).

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2004-01-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2006-04-26
• Last updated: 2014-11-07