Merci Registry - Real World Use of the Merci Retrieval System in Acute Ischemic Stroke

NCT ID: NCT00478478

Last Updated: 2014-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-09-30

Brief Summary

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Post-Market Registry on Use of Merci Retrieval System. Primary data to be collected will include:

* Post-procedure revascularization success
* 90-day mRS 0-2
* 90-day mortality

Detailed Description

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The Merci Registry is a prospective multicenter registry with up to 3000 patients enrolled at a maximum of 100 sites.

The registry requires use (at least one pass in the intracranial vasculature) of any Merci Retriever device (X Series, L Series, V Series) in the setting of acute ischemic stroke due to large vessel intracranial occlusion.

Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute Ischemic Stroke patients

Patients presenting with signs and symptoms consistent with a diagnosis of Acute Ischemic Stroke, who are treated with the Merci Retrieval System during a Mechanical Thrombectomy procedure.

Mechanical Thrombectomy

Intervention Type PROCEDURE

Thrombectomy performed with the Merci Retriever in the setting of acute ischemic stroke.

Interventions

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Mechanical Thrombectomy

Thrombectomy performed with the Merci Retriever in the setting of acute ischemic stroke.

Intervention Type PROCEDURE

Other Intervention Names

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Merci Retrieval System

Eligibility Criteria

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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 surrogate 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker Neurovascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wade S Smith, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California at San Francisco, SF, CA

Marilyn M Rymer, MD

Role: PRINCIPAL_INVESTIGATOR

MABSI St. Luke's, Kansas City, MO

Locations

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St. Luke's Brain and Stroke Institute

Kansas City, Missouri, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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INT-REG-001

Identifier Type: -

Identifier Source: org_study_id