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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Merci Retriever
Sponsored by
Stryker Neurovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Stroke, Ischemic, Thrombus, Embolectomy, Thrombectomy, Merci, Concentric, Embolus, Embolism, Mechanical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment

    Arm Description

    Treatment arm patients had at least one Merci Retriever deployed

    Outcomes

    Primary Outcome Measures

    Revascularization success; Rates of device-related serious adverse events

    Secondary Outcome Measures

    modified Rankin scores
    mortality
    Symptomatic hemorrhage rate

    Full Information

    First Posted
    July 14, 2005
    Last Updated
    November 6, 2014
    Sponsor
    Stryker Neurovascular
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00318071
    Brief Title
    Multi MERCI (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])
    Acronym
    Multi-MERCI
    Official Title
    A Multinational Controlled Registry to Evaluate the Concentric Merci Retriever System (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Stryker Neurovascular

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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)
    Detailed Description
    Per the Multi MERCI protocol, up to 230 patients could be treated at up to 30 centers. The intended trial indication for the Merci L5 Retriever was to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients that were contraindicated or failed treatment with intravenous t-PA were allowed to be enrolled under the Multi MERCI protocol. Per the Multi MERCI protocol, following inclusion of the Merci L5 Retriever the operating physician was required to initiate treatment with the Merci L5 Retriever. At the physician's discretion, subsequent passes could be made with the Merci L5 Retriever, Merci X6 Retriever and/or Merci X5 Retriever. Adverse events were adjudicated by an independent Data Safety and Monitoring Board (Capital DSMB).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Stroke
    Keywords
    Stroke, Ischemic, Thrombus, Embolectomy, Thrombectomy, Merci, Concentric, Embolus, Embolism, Mechanical

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    164 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    Treatment arm patients had at least one Merci Retriever deployed
    Intervention Type
    Device
    Intervention Name(s)
    Merci Retriever
    Intervention Description
    For patients eligible to participate in the trial, the operating physician initiated treatment with the Merci L5 Retriever to remove large vessel thrombotic occlusion and recanalization of the vessel. Subsequent treatment could be made with Merci X6 or X5 Merci Retrievers. Large vessel arteries are defined as internal carotid, middle cerebral M1/M2 segments, basilar, and vertebral arteries. Recanalization was defined as TIMI II or TIMI III per angiography.
    Primary Outcome Measure Information:
    Title
    Revascularization success; Rates of device-related serious adverse events
    Time Frame
    post-procedure
    Secondary Outcome Measure Information:
    Title
    modified Rankin scores
    Time Frame
    90-day
    Title
    mortality
    Time Frame
    90-day
    Title
    Symptomatic hemorrhage rate
    Time Frame
    24 hour post procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wade S Smith, MD, PhD
    Organizational Affiliation
    University of California, San Francisco
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18309168
    Citation
    Smith WS, Sung G, Saver J, Budzik R, Duckwiler G, Liebeskind DS, Lutsep HL, Rymer MM, Higashida RT, Starkman S, Gobin YP; Multi MERCI Investigators; Frei D, Grobelny T, Hellinger F, Huddle D, Kidwell C, Koroshetz W, Marks M, Nesbit G, Silverman IE. Mechanical thrombectomy for acute ischemic stroke: final results of the Multi MERCI trial. Stroke. 2008 Apr;39(4):1205-12. doi: 10.1161/STROKEAHA.107.497115. Epub 2008 Feb 28.
    Results Reference
    result
    PubMed Identifier
    16775259
    Citation
    Smith WS. Safety of mechanical thrombectomy and intravenous tissue plasminogen activator in acute ischemic stroke. Results of the multi Mechanical Embolus Removal in Cerebral Ischemia (MERCI) trial, part I. AJNR Am J Neuroradiol. 2006 Jun-Jul;27(6):1177-82.
    Results Reference
    result
    PubMed Identifier
    17332445
    Citation
    Flint AC, Duckwiler GR, Budzik RF, Liebeskind DS, Smith WS; MERCI and Multi MERCI Writing Committee. Mechanical thrombectomy of intracranial internal carotid occlusion: pooled results of the MERCI and Multi MERCI Part I trials. Stroke. 2007 Apr;38(4):1274-80. doi: 10.1161/01.STR.0000260187.33864.a7. Epub 2007 Mar 1.
    Results Reference
    result
    PubMed Identifier
    18346645
    Citation
    Lutsep HL, Rymer MM, Nesbit GM. Vertebrobasilar revascularization rates and outcomes in the MERCI and multi-MERCI trials. J Stroke Cerebrovasc Dis. 2008 Mar-Apr;17(2):55-7. doi: 10.1016/j.jstrokecerebrovasdis.2007.11.003.
    Results Reference
    result
    PubMed Identifier
    24876082
    Citation
    Shi ZS, Liebeskind DS, Xiang B, Ge SG, Feng L, Albers GW, Budzik R, Devlin T, Gupta R, Jansen O, Jovin TG, Killer-Oberpfalzer M, Lutsep HL, Macho J, Nogueira RG, Rymer M, Smith WS, Wahlgren N, Duckwiler GR; Multi MERCI, TREVO, and TREVO 2 Investigators. Predictors of functional dependence despite successful revascularization in large-vessel occlusion strokes. Stroke. 2014 Jul;45(7):1977-84. doi: 10.1161/STROKEAHA.114.005603. Epub 2014 May 29.
    Results Reference
    derived
    PubMed Identifier
    24789707
    Citation
    Liebeskind DS, Flint AC, Budzik RF, Xiang B, Smith WS, Duckwiler GR, Nogueira RG; MERCI and Multi-MERCI Investigators. Carotid I's, L's and T's: collaterals shape the outcome of intracranial carotid occlusion in acute ischemic stroke. J Neurointerv Surg. 2015 Jun;7(6):402-7. doi: 10.1136/neurintsurg-2014-011231. Epub 2014 May 1.
    Results Reference
    derived

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    Multi MERCI (Mechanical Embolus Removal in Cerebral Ischemia [MERCI™])

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