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

Medtronic

Status

Completed

Conditions

Ischemic Stroke

Treatments

Device: MERCI® Device

Device: SOLITAIRE™ Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT01054560

SWIFT

Details and patient eligibility

About

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.

Enrollment

144 patients

Sex

All

Ages

22 to 85 years old

Volunteers

No Healthy Volunteers

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