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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT00478478
First received: May 22, 2007
Last updated: November 6, 2014
Last verified: November 2014
  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 ] [ Designated as safety issue: Yes ]

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

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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT00478478     History of Changes
Other Study ID Numbers: INT-REG-001
Study First Received: May 22, 2007
Last Updated: November 6, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014