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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478478
• Other study ID #: INT-REG-001
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2007
• Last updated: November 6, 2014
• Start date: June 2007
• Est. completion date: September 2010

Study information

• Verified date: November 2014
• Source: Stryker Neurovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Procedure:
• Mechanical Thrombectomy
Thrombectomy performed with the Merci Retriever in the setting of acute ischemic stroke.

Locations

Country	Name	City	State
United States	St. Luke's Brain and Stroke Institute	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Neurovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-procedure revascularization success		post-procedure	Yes
Secondary	NIHSS change from baseline to 24-hours		24-hour	Yes
Secondary	90-day mRS outcomes		90-day	Yes
Secondary	90-day mortality		90-day	Yes

External Links

•   Stryker Neurovascular