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Completed

NCT Number: NCT01054560

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemia Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

22 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Stroke Center, Portland, Oregon, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOLITAIRE™ Device

Device

The SOLITAIRE™ Device is the experimental device that will be used in the interventional procedure

MERCI® Device

Device

The MERCI® Device is the control device that will be used in the interventional procedure.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Neurovascular Clinical Affairs

Industry

Registry information

Acronym: SWIFT

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 22, 2010
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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