Trial record 1 of 1 for:    NCT00478478
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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:
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT00478478
First received: May 22, 2007
Last updated: June 4, 2010
Last verified: June 2010
  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 Embolectomy
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: No ]
  • 90-day mRS 0-2 [ Time Frame: 90-day ] [ Designated as safety issue: No ]
  • 90-day mortality [ Time Frame: 90-day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • NIHSS change from baseline to 24-hours [ Time Frame: 24-hour ] [ Designated as safety issue: No ]
  • 90-day outcomes will be evaluated based on post-procedure revascularization status [ Time Frame: 90-day ] [ Designated as safety issue: No ]
  • Discharge Disposition [ Time Frame: variable ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: June 2007
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 Thrombectomy procedure.
Procedure: Mechanical Embolectomy
Thrombectomy
Other Name: Merci Retrieval System

  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: Gary Walker, PhD / Sr. Director Clinical Research, Concentric Medical
ClinicalTrials.gov Identifier: NCT00478478     History of Changes
Other Study ID Numbers: INT-REG-001
Study First Received: May 22, 2007
Last Updated: June 4, 2010
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:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 16, 2014