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

Active, not recruiting

Phase N/A Results N/A

Eligibility 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
- NIHSS≥8and<30
- Thrombolysis in Myocardial Infarction TIMI 0 or TIMI 1 flow in the M1 or M2 of MCA, ICA, 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 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