solitaire fr thrombectomy for acute revascularisation

Conditions: Stroke, Acute

Summary: the objective of this study was to obtain prospective clinical data on the safety and efficacy of the solitaire™ fr device for patients diagnosed with acute ischemic stroke.

the study was a multi-center, single-arm, prospective, observational evaluation. the solitaire™ fr device has been certified for ce mark. this protocol evaluated the safety and efficacy of the solitaire™ fr device when used in routine practice and according to its instructions for use.

Eligibility criteria:
inclusion criteria: 1. subject or subject's legally authorized representative has signed and dated an informed consent form 2. age ≥ 18 and \< 85 3. clinical signs consistent with acute ischemic stroke 4. thrombolysis in cerebral infarction (tici) 0 or tici 1 flow in the proximal anterior intracranial vasculature (m1 or m2 of middle cerebral artery (mca), internal carotid artery (ica) intracranial, internal carotid artery (ica) terminal) 5. presentation within 8 hours of stroke onset according to local stroke protocol 6. if stroke presentation within 4.5 hours, one of these conditions can be met: * bridging protocol (starting intravenous and continuing with intra-arterial) (up to maximum 0.9 mg/kg) * failed intravenous thrombolysis * direct intra-arterial treatment (according to institution guidelines) 7. subject is willing to conduct follow-up visits. 8. national institutes of health stroke scale (nihss) ≥ 8 and ≤ 30 9. modified rankin scale (mrs) ≤ 2 prior to stroke onset exclusion criteria: 1. females who are pregnant or lactating 2. known serious sensitivity to radiographic contrast agents 3. neurological signs that are rapidly improving prior to or at time of treatment 4. current participation in another investigational drug or device study 5. life expectancy of less than 90 days 6. national institutes of health stroke scale (nihss) \> 30 or coma 7. uncontrolled hypertension defined as systolic blood pressure \> 185 or diastolic blood pressure \> 110 that cannot be controlled except with continuous parenteral antihypertensive medication 8. use of warfarin anticoagulation with international normalised ratio (inr) \> 3.0 9. platelet count \< 30,000 10. glucose \< 400 mg/dl 11. previous stroke within 30 days 12. time of symptom onset unknown 13. seizure at the onset of stroke 14. myocardial infarction or infection (sepsis or endocarditis) 15. arterial tortuosity that would prevent the device from reaching the target vessel 16. known hypersensitivity to nickel-titanium imaging exclusion criteria: 17. angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis 18. stenosis proximal to thrombus site that may preclude safe recovery of the device 19. brain computed tomography (ct) with signs of hemorrhage, arteriovenous venous malformations, or aneurysm 20. early ischemic changes greater than 1/3 of the middle cerebral artery (mca) territory or according to brain computed tomography (ct) alberta stroke program early ct (aspect) score ≤ 6 or according to magnetic resonance diffusion weighted imaging (mr dwi) aspect score \<5

Keywords: solitaire fr device mechanical thrombectomy recanalization brain artery recanalization neurovascular intervention interventional neuroradiology star acute ischemic stroke