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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00318071
Recruitment Status : Completed
First Posted : April 26, 2006
Last Update Posted : November 7, 2014
Information provided by (Responsible Party):
Stryker Neurovascular

July 14, 2005
April 26, 2006
November 7, 2014
January 2004
December 2006   (Final data collection date for primary outcome measure)
Revascularization success; Rates of device-related serious adverse events [ Time Frame: post-procedure ]
Revascularization success; Rates of procedure-related serious adverse events
Complete list of historical versions of study NCT00318071 on Archive Site
  • modified Rankin scores [ Time Frame: 90-day ]
  • mortality [ Time Frame: 90-day ]
  • Symptomatic hemorrhage rate [ Time Frame: 24 hour post procedure ]
  • 30/90 day modified Rankin scores;
  • 90 day mortality;
  • Symptomatic hemorrhage rate
Not Provided
Not Provided
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™])

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)

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).

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ischemic Stroke
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.

Experimental: Treatment
Treatment arm patients had at least one Merci Retriever deployed
Intervention: Device: Merci Retriever

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2006
December 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Angiographically confirmed large vessel ischemic stroke (occlusion may include the following: internal carotid artery (ICA), M1/M2, vertebral, or basilar arteries)
  • Intervention is able to be performed within 8 hours of symptom onset
  • Patients > 18 years of age
  • NIHSS score 8+
  • Failed IV t-PA treatment or contraindicated for IV t-PA

Exclusion Criteria:

  • International Normalized Ratio (INR) > 3.0
  • Platelet count < 30,000
  • Heparin use in previous 24 hours with PTT > 2X normal
  • Baseline bloog glucose < 50 mg/dL
  • Baseline computed tomography (CT) showing mass effect with midline shift
  • Severe sustained hypertension (SBP > 185 or DBP > 110) that cannot be controlled with medication
  • Patient is pregnant, has anticipated life expectancy < 3 months, or has severe allergy to contrast medium
  • Arterial stenosis > 50% proximal to embolus
  • Excessive arterial tortuosity that precludes the study device from reaching the target area
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
Not Provided
Not Provided
Stryker Neurovascular
Stryker Neurovascular
Not Provided
Principal Investigator: Wade S Smith, MD, PhD University of California, San Francisco
Stryker Neurovascular
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP