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

Sponsor

Stryker Neurovascular (Industry)

Overall Status

Completed

CT.gov ID

NCT00478478

Collaborator

(none)

1,000

Enrollment

Location

Duration (Months)

25.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Procedure: Mechanical Thrombectomy

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 Design

Study Type:

Observational

Actual Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Post-procedure revascularization success [post-procedure]

Secondary Outcome Measures

NIHSS change from baseline to 24-hours [24-hour]
90-day mRS outcomes [90-day]
90-day mortality [90-day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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