Status:
COMPLETED
Multi MERCI (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])
Lead Sponsor:
Stryker Neurovascular
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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 fo...
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00318071
Start Date
January 1 2004
End Date
December 1 2006
Last Update
November 7 2014
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