SOLITAIRE⢠FR With the Intention For Thrombectomy (SWIFT) Study (NCT01054560) | Clinical Trial Compass
CompletedNot Applicable
SOLITAIRE⢠FR With the Intention For Thrombectomy (SWIFT) Study
United States144 participantsStarted 2010-01
Plain-language summary
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.
Who can participate
Age range22 Years ā 85 Years
SexALL
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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) ā„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 MERCIĀ® Device
* Patient is able to be treated within 8 hours of stroke symptoms onset with minimum of one deployment of the SOLITAIRETM or MERCIĀ® 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 ā¦
What they're measuring
1
Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage
Timeframe: Immediately post treatment
2
Study Device-related Serious Adverse Events (SAEs)