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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
  Purpose
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 Intervention
Ischemic Stroke
Device: SOLITAIRE™ Device
Device: MERCI® Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study

Further study details as provided by Medtronic Neurovascular Clinical Affairs:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Enrollment: 144
Study Start Date: January 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   22 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054560

Locations
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
Principal Investigator: Jeffrey L. Saver, MD University of California, Los Angeles
  More Information

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

Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT01054560     History of Changes
Other Study ID Numbers: SWIFT 
Study First Received: December 10, 2009
Results First Received: April 24, 2012
Last Updated: August 31, 2016
Health Authority: United States: Food and Drug Administration

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:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 02, 2016