N/A
Completed N=113
SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study
Source: ClinicalTrials.gov NCT01054560 ↗Enrolled (actual)
113
Serious AEs
82.3%
Results posted
Oct 2016
Primary outcomePrimary: Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage — 60.7; 24.1 Percent of Subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage |
60.7; 24.1 | — |
| PRIMARY Study Device-related Serious Adverse Events (SAEs) |
9; 16 | — |
| PRIMARY Procedure-related Serious Adverse Events (SAEs) |
14; 16 | — |
| SECONDARY Time to Initial Recanalization |
47; 58.7 | — |
| SECONDARY Good Neurological Outcome at 30 Days |
50.9; 33.3 | — |
| SECONDARY Good Neurological Outcome 90 Days |
58.2; 33.3 | — |
| SECONDARY Mortality |
17.2; 38.2 | — |
| SECONDARY Symptomatic Intracranial Hemorrhage |
1.7; 10.9 | — |
| SECONDARY Non-fatal Stroke-related Morbidity |
43.1; 32.7 | — |
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
- National Institutes of Health Stroke Scale (NIHSS) ≥8and 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 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
Data sourced from ClinicalTrials.gov (NCT01054560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.