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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier:
NCT01054560
First received: December 10, 2009
Last updated: August 31, 2016
Last verified: August 2016

December 10, 2009
August 31, 2016
January 2010
July 2011   (final data collection date for primary outcome measure)
  • Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage [ Time Frame: Immediately post treatment ] [ Designated as safety issue: No ]

    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)

  • Study Device-related Serious Adverse Events (SAEs) [ Time Frame: 90 Day ] [ Designated as safety issue: Yes ]
    Incidence of study device-related Serious Adverse Events (SAEs)
  • Procedure-related Serious Adverse Events (SAEs) [ Time Frame: 90 Day ] [ Designated as safety issue: Yes ]
    Incidence of study procedure-related Serious Adverse Events (SAEs)
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. [ Time Frame: Immediately post treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01054560 on ClinicalTrials.gov Archive Site
  • Time to Initial Recanalization [ Time Frame: post treatment ] [ Designated as safety issue: No ]
    Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow
  • Good Neurological Outcome at 30 Days [ Time Frame: 30 Days Follow-up ] [ Designated as safety issue: No ]
    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
  • Good Neurological Outcome 90 Days [ Time Frame: 90 Days Follow-up ] [ Designated as safety issue: No ]
    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
  • Mortality [ Time Frame: 90 Days follow-up ] [ Designated as safety issue: Yes ]
    Rate of Mortality
  • Symptomatic Intracranial Hemorrhage [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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.
  • Non-fatal Stroke-related Morbidity [ Time Frame: 90 Day ] [ Designated as safety issue: Yes ]
    Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events
Time to initial recanalization Measurement of patient's neurological condition including NIH Stroke Scale, Barthel Index and Modified Rankin Score at 30 and 90 days post procedure Rate of morbidity and mortality Incidence of symptomatic hemorrhage [ Time Frame: 30 and 90 days post treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study
SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ischemic Stroke
  • Device: SOLITAIRE™ Device
    The SOLITAIRE™ Device is the experimental device that will be used in the interventional procedure
  • Device: MERCI® Device
    The MERCI® Device is the control device that will be used in the interventional procedure.
  • Experimental: SOLITAIRE™ Device
    The SOLITAIRE™ Device (investigational device) is the experimental arm
    Intervention: Device: SOLITAIRE™ Device
  • Active Comparator: MERCI® Device
    The MERCI® Device (control device) is commercially available.
    Intervention: Device: MERCI® Device

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
22 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01054560
SWIFT
Yes
Not Provided
Not Provided
Medtronic Neurovascular Clinical Affairs
Medtronic Neurovascular Clinical Affairs
Not Provided
Principal Investigator: Jeffrey L. Saver, MD University of California, Los Angeles
Medtronic Neurovascular Clinical Affairs
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP