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

This study has been completed.
Information provided by:
Stryker Neurovascular Identifier:
First received: July 14, 2005
Last updated: April 15, 2008
Last verified: April 2008

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)

Condition Intervention
Ischemic Stroke
Device: Merci Retriever

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multinational Controlled Registry to Evaluate the Concentric Merci Retriever System (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])

Resource links provided by NLM:

Further study details as provided by Stryker Neurovascular:

Primary Outcome Measures:
  • Revascularization success; Rates of device-related serious adverse events [ Time Frame: post-procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • modified Rankin scores [ Time Frame: 90-day ] [ Designated as safety issue: No ]
  • mortality [ Time Frame: 90-day ] [ Designated as safety issue: Yes ]
  • Symptomatic hemorrhage rate [ Time Frame: 24 hour post procedure ] [ Designated as safety issue: Yes ]

Enrollment: 164
Study Start Date: January 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Treatment arm patients had at least one Merci Retriever deployed
Device: Merci Retriever


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00318071

Sponsors and Collaborators
Stryker Neurovascular
Principal Investigator: Wade S Smith, MD, PhD University of California, San Francisco
  More Information

Additional Information:
Responsible Party: Concentric Medical Identifier: NCT00318071     History of Changes
Other Study ID Numbers: INT-LR-001
Study First Received: July 14, 2005
Last Updated: April 15, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Stryker Neurovascular:

Additional relevant MeSH terms:
Cerebral Infarction
Brain Ischemia
Brain Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on April 16, 2014