capture registration trial of the thrombectomy system for the treatment of acute ischemic stroke.

Conditions: Acute Ischemic Stroke

Summary: as this will be a pre-market registration trial, in which devices will be used in accordance with appropriately labeled indications, pre-study notifications and approval requests will be addressed with cfda. all trial results will be shared with cfda.


Eligibility criteria:
inclusion criteria: * subject must demonstrate clinical signs and symptoms that are attributable to the targeted lesion and are consistent with the diagnosis of acute ischemic stroke (ais), as confirmed by a neuroradiologist (or equivalent expert), using appropriate imaging. arterial occlusion of ica, mca-m1 or mca-m2. * female or male subject, who, at the time of consenting, is aged between 18 and 80 years, inclusive. * within 6 hours of stroke symptom onset, subject must have undergone treatment initiation (vascular access through puncture or cut down). * signed informed consent form (icf) completed by subject or subject's legal representative. exclusion criteria: * 1. functional dependence prior to stroke onset, defined as a pre-stroke modified rankin scale (mrs) score of ≥2. * 2. subject's baseline nihss score \ 25. * 3. history of severe head injury within past 90 days with residual neurological deficit, as determined by medical history. * 4. pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor. * 5. seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline nihss assessment. * 6. subject has a known hemorrhagic diathesis, coagulation factor deficiency; or, is on oral anticoagulant therapy and has an international normalized ratio (inr) \>3. * 7. subject's baseline platelet count is \<30\*10\^9/l. * 8. subject's baseline glucose is \ 400 mg/dl (22.2 mmol/l). * 9. renal failure, as defined by a serum creatinine \>3.0 mg/dl (264 µmol/l) \[note: subjects on renal dialysis may be treated regardless of serum creatinine levels\]. * 10. severe, sustained hypertension (sbp \> 185 mm hg or dbp \> 110 mmhg) \[if the blood pressure can be successfully reduced and maintained at the acceptable level, using medication, the patient can be enrolled\]. * 11. subject has known allergy or contraindication to one or more of the following: anti-platelet drugs; contrast dye; and/or, local or general anesthesia. * 12. subject has known allergy to nickel, cobalt chromium, tungsten, platinum or other metal that may be a component of a required medical device needed for treatment. * 13. subject is generally unsuitable for endovascular intervention or anesthesia. * 14. subject has had major surgery within the previous 30 days * 15. subject is an active participant in another drug or device treatment trial for any disease state; or, subject is expected to start participation in another drug or device trial while enrolled in this protocol. * 16. subject currently has infective endocarditis or other severe, active bacterial infection. * 17. subject's life expectancy is less than 6 months. * 18. female of childbearing potential who is known to be pregnant and/or lactating or who has a positive pregnancy test on admission. imaging exclusion criteria: * 19. subject has ct scan or mri evidence of the following: * significant mass effect with midline shift. * evidence of intracranial tumor, except small meningioma. * evidence of intracranial hemorrhage. * evidence of internal carotid artery flow limiting dissection. * suspected cerebral vasculitis. * suspected aortic dissection. * occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) or clinical evidence of bilateral strokes or strokes in multiple territories. * 20. the presence of a large completed territorial infarction by non-contrast ct (ncct), defined as an alberta stroke program early ct score (aspects) ≤5. * 21. other unusual morphology or lesion that might interfere with device use, including but not limited to the following: * carotid dissection * vasculitis * aortic dissection * aneurysm * no transfemoral or alternative access, such as: 1. severe intracranial tortuosity 2. severe intracranial vasospasm, unresponsive to pharmacotherapy. 3. other anatomical or clinical conditions contraindicated for access. * 22. anterior circulation strokes involving \> 1/3 of the mca territory, as determined by hypo-density on the baseline non-contrast ct, or low cbv on ct perfusion imaging, or restricted diffusion on dwi images. * 23. thrombotic occlusion in the posterior circulation arteries (vertebral, basilar, etc.) * 24. intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the thrombectomy device.