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

Ischemic Stroke Clinical Trial

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

Status Completed

Clinical Trial 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)

Clinical Trial 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). ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemic Stroke

• NCT number: NCT00318071
• Study type: Interventional
• Source: Stryker Neurovascular
• Status: Completed
• Phase: N/A
• Start date: January 2004
• Completion date: December 2006