Multi MERCI (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])
Information source: Concentric Medical
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ischemic Stroke
Intervention: Merci Retriever (Device)
Phase: N/A
Status: Completed
Sponsored by: Concentric Medical Official(s) and/or principal investigator(s):
Wade S Smith, MD, PhD, Principal Investigator, Affiliation: University of California, San Francisco
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 Details
Official title: A Multinational Controlled Registry to Evaluate the Concentric Merci Retriever System (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Revascularization success; Rates of device-related serious adverse events
Secondary outcome: modified Rankin scoresmortality Symptomatic hemorrhage rate
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Concentric Medical Website
Starting date: January 2004
Ending date: December 2006
Last updated: April 15, 2008
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