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

This study is currently recruiting participants.

Verified by Concentric Medical, November 2008

First Received: May 22, 2007 Last Updated: November 17, 2008 History of Changes

Sponsored by:	Concentric Medical
Information provided by:	Concentric Medical
ClinicalTrials.gov Identifier:	NCT00478478

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 IV

U.S. FDA Resources

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

Further study details as provided by Concentric Medical:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	3000
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

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 (IV or IA) 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 legally authorized representative (LAR) 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478478

Contacts

Contact: Gary Walker, PhD	650-810-1736	gwalker@concentric-medical.com
Contact: Cindy Jahans, BSc	650-810-1729	cjahans@concentric-medical.com

Locations

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

Sponsors and Collaborators

Concentric Medical

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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Concentric Medical ( Gary Walker, PhD / Sr. Director Clinical Research )
Study ID Numbers:	INT-REG-001
Study First Received:	May 22, 2007
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00478478 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Concentric Medical:

Stroke
Ischemic
Thrombus
Embolectomy
Thrombectomy

Merci
Concentric
Embolus
Embolism
Mechanical

Study placed in the following topic categories:

Cerebral Infarction
Embolism
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases

Brain Infarction
Ischemia
Brain Diseases
Infarction
Cerebrovascular Disorders
Thrombosis

Additional relevant MeSH terms:

Pathologic Processes
Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Brain Ischemia

Central Nervous System Diseases
Cardiovascular Diseases
Brain Infarction
Ischemia
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on May 07, 2009