Solitaire FR Thrombectomy for Acute Revascularisation
Solitaire FR Thrombectomy for Acute Revascularisation
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.
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