Merci Registry
Merci Registry
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Status:
Ongoing. This is a registry and is currently enrolling patients and centers, with no maximum number of participants to enroll.
Purpose:
To assess real world use of the Merci Retriever for thrombus removal in acute ischemic stroke.
Interventions:
Concentric Merci Retrievers
Remove the clot by putting an FDA approved device through the clot and pulling it back to remove the attached clot into the tube and pulling it out of your body. If your doctor first attempts to remove the clot with such a device, you may still receive rt-PA if some of the clot is still present.
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Location(s):
50+ sites worldwide
Year Started:
2007
Year Presented:
2009
Design:
Prospective, open-label, competitive enrollment, multi-center, multi-national Registry.
Inclusion Criteria
Patient with ischemic stroke is treated with a Merci Retriever that is indicated for thrombus removal in ischemic stroke. “Treated” is defined as being when a Merci Retriever is deployed in the neurovasculature of a patient with an ischemic stroke.
Patient/patient’s legally authorized representative (LAR) provides informed consent and is willing to comply with the protocol requirements and complete required clinical evaluations, or in the absence of informed consent, an IRB/EC approved waiver of consent and executed data use agreement are in place.
Exclusion Criteria
There are no exclusion criteria for this protocol.
Patient Involvement:
Patient assessed post-procedure for revascularization success, at 24 hours for change from baseline NIHSS, and at 90 day for mRS.
Primary Outcome:
Post-procedure revascularization success; 90-day mRS 0-2; 90-day mortality rate.
Secondary Outcome:
NIHSS change from baseline to 24-hours; length of hospital stay (# days); discharge disposition.
Source of Information:
Correspondence with registry coordinator.
ClinicalTrials.gov
Preliminary data presented at 2/21/08 at an investigators' meeting.
Abstract presented at 2008 International Stroke Conference (February 2008).
Abstract presented at 2009 International Stroke Conference (February 2009).
Oral presentation at SNIS meeting 2009 by Dr. Blaise Baxter titled “Does Anesthesia Influence Clinical Outcomes in Mechanical Embolectomy? Real World Data From The Merci Registry.”
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Web Links and Publications:
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This information last updated on: 10/13/2009
Reviewed on: 10/13/2009.
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