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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00478478
First Posted: May 24, 2007
Last Update Posted: November 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stryker Neurovascular
  Purpose

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

Condition Intervention Phase
Ischemic Stroke Procedure: Mechanical Thrombectomy Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Merci Registry - Real World Use of the Merci Retrieval System in Acute Ischemic Stroke

Further study details as provided by Stryker Neurovascular:

Primary Outcome Measures:
  • Post-procedure revascularization success [ Time Frame: post-procedure ]

Secondary Outcome Measures:
  • NIHSS change from baseline to 24-hours [ Time Frame: 24-hour ]
  • 90-day mRS outcomes [ Time Frame: 90-day ]
  • 90-day mortality [ Time Frame: 90-day ]

Enrollment: 1000
Study Start Date: June 2007
Study Completion Date: September 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Merci Retrieval System

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478478


Locations
United States, Missouri
St. Luke's Brain and Stroke Institute
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
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
  More Information

Additional Information:
Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT00478478     History of Changes
Other Study ID Numbers: INT-REG-001
First Submitted: May 22, 2007
First Posted: May 24, 2007
Last Update Posted: November 10, 2014
Last Verified: November 2014

Keywords provided by Stryker Neurovascular:
Stroke
Ischemic
Thrombus
Embolectomy
Thrombectomy
Merci
Concentric
Embolus
Embolism
Mechanical

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia