CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 127 enrolled
Drug / intervention
Merci Retriever and Penumbra Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00389467
NCT00389467Phase 2Completed
CompareCT.gov

Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy

University of California, Los Angeles·interventional·Posted Oct 18, 2006·Updated Mar 26, 2014

In Brief

A Phase 2 clinical trial evaluating Merci Retriever and Penumbra System for Stroke. Completed, enrolled 127 participants across 22 sites in 2 countries.

Detailed Summary

The purpose of this study is to compare the effectiveness of treating acute ischemic stroke with mechanical embolectomy using the Merci Retriever or the Penumbra System within 8 hours of symptom onset to standard medical treatment, and to identify people who might benefit from mechanical embolectomy by the appearance of stroke on multimodal computerized tomography (CT) or magnetic resonance (MR) imaging.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesCanada, United States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 18, 2006
Enrollment StartMay 1, 2004
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 19.7 years ago

Interventions

Merci Retriever and Penumbra Systemdevice

The MERCI (Mechanical Embolus Removal in Cerebral Ischemia) Retriever consists of a flexible, nickel titanium (nitinol) wire with a helical-shaped distal tip. The helical distal tip is covered with a platinum radiopaque coil, which facilitates fluoroscopic visualization. The body of the MERCI Retriever is covered with a hydrophilic coating that helps facilitate device placement. The MERCI Retriever is available in 6 configurations (Merci Retrievers X6, L5, L4, L6, V series, DAC). The Penumbra System uses a reperfusion catheter in parallel with a separator component and an aspiration source to achieve separation of the thrombus and subsequent aspiration of the occlusion from the vessel. The system is available in different sizes according to the target vessels (041 Reperfusion Catheter/Separator pair for use in vessels larger than 3mm, notably the ICA and M1; 032 Reperfusion Catheter/Separator pair for use in vessels 2mm - 3mm, notably the M2).