Multi MERCI (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™]) - Full Text View

Sponsor:	Concentric Medical
Information provided by:	Concentric Medical
ClinicalTrials.gov Identifier:	NCT00318071

Purpose

The primary objectives of the Multi MERCI trial were:

to evaluate the addition of the Merci L5 Retriever
additionally permit use of the Merci Retrieval System in the setting of persistent clot following IV t-PA treatment (use in the 0-8 hour window for patients ineligible for IV t-PA was also permitted)

Condition	Intervention
Ischemic Stroke	Device: Merci Retriever

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multinational Controlled Registry to Evaluate the Concentric Merci Retriever System (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])

Further study details as provided by Concentric Medical:

Primary Outcome Measures:

Revascularization success; Rates of device-related serious adverse events [ Time Frame: post-procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

modified Rankin scores [ Time Frame: 90-day ] [ Designated as safety issue: No ]
mortality [ Time Frame: 90-day ] [ Designated as safety issue: Yes ]
Symptomatic hemorrhage rate [ Time Frame: 24 hour post procedure ] [ Designated as safety issue: Yes ]

Enrollment:	164
Study Start Date:	January 2004
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment: Experimental Treatment arm patients had at least one Merci Retriever deployed	Device: Merci Retriever

Eligibility

Criteria

Inclusion Criteria:

Angiographically confirmed large vessel ischemic stroke (occlusion may include the following: internal carotid artery (ICA), M1/M2, vertebral, or basilar arteries)
Intervention is able to be performed within 8 hours of symptom onset
Patients > 18 years of age
NIHSS score 8+
Failed IV t-PA treatment or contraindicated for IV t-PA

Exclusion Criteria:

International Normalized Ratio (INR) > 3.0
Platelet count < 30,000
Heparin use in previous 24 hours with PTT > 2X normal
Baseline bloog glucose < 50 mg/dL
Baseline computed tomography (CT) showing mass effect with midline shift
Severe sustained hypertension (SBP > 185 or DBP > 110) that cannot be controlled with medication
Patient is pregnant, has anticipated life expectancy < 3 months, or has severe allergy to contrast medium
Arterial stenosis > 50% proximal to embolus
Excessive arterial tortuosity that precludes the study device from reaching the target area

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318071

Sponsors and Collaborators

Concentric Medical

Investigators

Principal Investigator:

Wade S Smith, MD, PhD

University of California, San Francisco

More Information

Additional Information:

Concentric Medical Website This link exits the ClinicalTrials.gov site

Publications:

Responsible Party:	Concentric Medical
Study ID Numbers:	INT-LR-001
Study First Received:	July 14, 2005
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00318071 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Concentric Medical:

Stroke
Ischemic
Thrombus
Embolectomy
Thrombectomy

Merci
Concentric
Embolus
Embolism
Mechanical

Additional relevant MeSH terms:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases

Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on February 08, 2010