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

November 6, 2014 updated by: Stryker Neurovascular

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Brain and Stroke Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients with ischemic stroke treated with a Merci Retriever either alone or in combination with adjunctive therapies such as lytics will be included in the Registry.

Description

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

Exclusion Criteria:

-There are no exclusion criteria for this protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Mechanical Thrombectomy
Thrombectomy performed with the Merci Retriever in the setting of acute ischemic stroke.
Other Names:
  • Merci Retrieval System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-procedure revascularization success
Time Frame: post-procedure
post-procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
90-day mortality
Time Frame: 90-day
90-day
NIHSS change from baseline to 24-hours
Time Frame: 24-hour
24-hour
90-day mRS outcomes
Time Frame: 90-day
90-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stryker Neurovascular

Investigators

  • Principal Investigator: Wade S Smith, MD, PhD, University of California at San Francisco, SF, CA
  • Principal Investigator: Marilyn M Rymer, MD, MABSI St. Luke's, Kansas City, MO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

May 22, 2007

First Submitted That Met QC Criteria

May 23, 2007

First Posted (Estimate)

May 24, 2007

Study Record Updates

Last Update Posted (Estimate)

November 10, 2014

Last Update Submitted That Met QC Criteria

November 6, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT-REG-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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