Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00318071
Status:
COMPLETED
Last Update Posted:
2014-11-07
First Post:
2005-07-14
Brief Title:
Multi MERCI Mechanical Embolus Removal in Cerebral Ischemia MERCI
Sponsor:
Stryker Neurovascular
Organization:
Stryker Neurovascular
Study Overview
Official Title:
A Multinational Controlled Registry to Evaluate the Concentric Merci Retriever System Mechanical Embolus Removal in Cerebral Ischemia MERCI
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Multi-MERCI
Brief 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
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 physicians discretion subsequent passes could be made with the Merci L5 Retriever Merci X6 Retriever andor Merci X5 Retriever
Adverse events were adjudicated by an independent Data Safety and Monitoring Board Capital DSMB
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 physicians discretion subsequent passes could be made with the Merci L5 Retriever Merci X6 Retriever andor Merci X5 Retriever
Adverse events were adjudicated by an independent Data Safety and Monitoring Board Capital DSMB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None