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

NCT00478478 | Completed

• 1 other identifier: INT-REG-001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Ischemic Stroke

Keywords

Stroke; Ischemic; Thrombus; Embolectomy; Thrombectomy; Merci; Concentric; Embolus; Embolism; Mechanical

Outcome Measures

Primary Outcomes (1)

• Post-procedure revascularization success

  post-procedure

Secondary Outcomes (3)

• NIHSS change from baseline to 24-hours

  24-hour

• 90-day mRS outcomes

  90-day

• 90-day mortality

  90-day

Study Arms (1)

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

Interventions

Mechanical Thrombectomy PROCEDURE

Thrombectomy performed with the Merci Retriever in the setting of acute ischemic stroke.

Also known as: Merci Retrieval System

Acute Ischemic Stroke patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Stryker Neurovascular: lead

Study Sites (1)

St. Luke's Brain and Stroke Institute

Kansas City, Missouri, 64111, United States

Location

Related Links

• Stryker Neurovascular

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Ischemia; Thrombosis; Embolism

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2007
• First Posted: May 24, 2007
• Study Start: June 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 10, 2014

Record last verified: 2014-11

Locations

US (1)