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SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study (SWIFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01054560
Recruitment Status : Completed
First Posted : January 22, 2010
Results First Posted : October 26, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Study Description
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Brief Summary:
The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval System® (MERCI® Device). The study will demonstrate safety and efficacy of the SOLITAIRE™ Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Device: SOLITAIRE™ Device Device: MERCI® Device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study
Study Start Date : January 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Experimental: SOLITAIRE™ Device
The SOLITAIRE™ Device (investigational device) is the experimental arm
 Device: SOLITAIRE™ Device
The SOLITAIRE™ Device is the experimental device that will be used in the interventional procedure
Active Comparator: MERCI® Device
The MERCI® Device (control device) is commercially available.
 Device: MERCI® Device
The MERCI® Device is the control device that will be used in the interventional procedure.


Outcome Measures
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Primary Outcome Measures :
  1. Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage [ Time Frame: Immediately post treatment ]

    Successful arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes.

    Thrombolysis in Myocardial Infarction (TIMI) score describes the distal flow perfusion and revascularization before and following therapy.

    TIMI 0 - No perfusion (worst outcome) TIMI 1 - Perfusion past the initial occlusion, but no distal branch filling TIMI 2 - Perfusion with incomplete or slow distal branch filling TIMI 3 - Full perfusion with filling of all distal branches (best outcome)


  2. Study Device-related Serious Adverse Events (SAEs) [ Time Frame: 90 Day ]
    Incidence of study device-related Serious Adverse Events (SAEs)

  3. Procedure-related Serious Adverse Events (SAEs) [ Time Frame: 90 Day ]
    Incidence of study procedure-related Serious Adverse Events (SAEs)


Secondary Outcome Measures :
  1. Time to Initial Recanalization [ Time Frame: post treatment ]
    Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow

  2. Good Neurological Outcome at 30 Days [ Time Frame: 30 Days Follow-up ]
    Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more

  3. Good Neurological Outcome 90 Days [ Time Frame: 90 Days Follow-up ]
    Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more

  4. Mortality [ Time Frame: 90 Days follow-up ]
    Rate of Mortality

  5. Symptomatic Intracranial Hemorrhage [ Time Frame: 24 hours ]
    Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs.

  6. Non-fatal Stroke-related Morbidity [ Time Frame: 90 Day ]
    Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient or patient's legally authorized representative has signed and dated an Informed Consent Form
  • Age22-85
  • Clinical signs consistent with acute ischemic stroke
  • National Institutes of Health Stroke Scale (NIHSS) ≥8and<30
  • Thrombolysis in Myocardial Infarction (TIMI) 0 or TIMI 1 flow in the M1 or M2 of middle cerebral artery, internal carotid artery, basilar or vertebral arteries confirmed by angiography that is accessible to the SOLITAIRETM or MERCI® Device
  • Patient is able to be treated within 8 hours of stroke symptoms onset with minimum of one deployment of the SOLITAIRETM or MERCI® Device.
  • Patient who is ineligible or failed intravenous tissue plasminogen activator (t-PA) therapy given at local institutions or within national practice.
  • Patient is willing to conduct follow-up visits

Exclusion Criteria:

  • NIHSS > 30 or coma
  • Neurological signs that are rapidly improving prior to or at time of treatment
  • Females who are pregnant or lactating
  • Known serious sensitivity to radiographic contrast agents
  • Current participation in another investigation drug or device study
  • Uncontrolled hypertension defined as systolic blood pressure > 185 or diastolic blood pressure > 110 that cannot be controlled except with continuous parenteral antihypertensive medication
  • Use of warfarin anticoagulation with International Normalized Ratio (INR) > 3.0
  • Platelet count < 30,000
  • Glucose < 50 mg/dL
  • Arterial tortuosity that would prevent the device from reaching the target vessel
  • Life expectancy of less than 90 days
  • Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation
  • CT showing hypodensity or MR showing hyperintensity involving greater than 1/3 of the middle cerebral artery (MCA) territory (or in other territories, >100 cc of tissue) on presentation
  • CT or MRI evidence of mass effect or intracranial tumor (except small meningioma)
  • Angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054560


Locations
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United States, Oregon
Oregon Stroke Center
Portland, Oregon, United States
United States, Washington
Multicare Health System
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Investigators
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Principal Investigator: Jeffrey L. Saver, MD University of California, Los Angeles
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT01054560    
Other Study ID Numbers: SWIFT
First Posted: January 22, 2010    Key Record Dates
Results First Posted: October 26, 2016
Last Update Posted: October 26, 2016
Last Verified: August 2016
Keywords provided by Medtronic Neurovascular Clinical Affairs:
Ischemic Stroke
SOLITAIRE™ Device
SOLITAIRE™
MERCI® Device
MERCI®
Stroke
Ischemic
Mechanical Thrombectomy
Brain
Brain Clot
 Brain Artery Revascularization
Recanalization
Brain Stroke
Clot Retriever
Device
Neurosurgery
Neurovascular Intervention
Interventional Neuroradiology
Brain study
neurovascular clinical trial
Additional relevant MeSH terms:
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Ischemic Stroke
Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases