Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever

Korábbi kezelés

• Use of any other intra-arterial (IA) recanalization device prior to the Tigertriever 13 in the target vessel, including aspiration catheter.
• Excessive tortuosity or stenosis that is anticipated to prevent placement of the microcatheter in the target vessel. Tortuosity or stenosis will be determined on CTA or MRA prior to randomization.
• Prior stroke in the last 3 months.
• Treatment with a direct oral anticoagulant (DOAC) within 48 hours.

Más betegség

• Evidence of acute brain hemorrhage on CT and/or MRI at admission.
• Evidence of bilateral acute stroke or acute stroke in multiple territories (e.g., bilateral anterior circulation, anterior/posterior circulation).
• Pre-procedural severe sustained hypertension with SBP >220 and/or DBP >120.
• History of severe allergy to contrast medium, nickel, or Nitinol.
• Ongoing seizure due to stroke.
• Evidence of active systemic infection.
• Known cancer with metastases.

Laborértékek

• Renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30.
• Pre-procedural glucose <50 mg/dl (2.78 mmol/L) or >400 mg/dl (22.20 mmol/L).
• Pre-procedural coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 1.7.
• Treatment with heparin within 48 hours with a partial thromboplastin time more than two times the laboratory normal.
• Platelet count of less than 50,000/uL.

Egyéb

• The DVO is a secondary distal occlusion that occurred during a large vessel occlusion (LVO) thrombectomy procedure.
• Evidence of tandem occlusion in the cervical internal carotid artery (ICA), intracranial ICA, M1 MCA, dominant M2 MCA, vertebral artery (VA) or basilar artery (BA) on CTA or MRA.
• Evidence of dissection in the extra or intracranial cerebral arteries.
• Anticipated inability to obtain 3-month follow-up assessments.
• Females who are pregnant or breastfeeding.
• Known current use of cocaine at time of treatment.
• Known or suspected cerebral vasculitis.
• Known hemorrhagic diathesis.
• Aneurysm in target vessel.
• Intracranial tumor (apart from small meningioma, ≤2 cm in diameter).
• Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
• Subject already participating in another study of an investigational treatment device or treatment.

• Age 18-85 years old.
• Pre-stroke mRS ≤2.
• Disabling presenting deficits that localize to the territory of the distal vessel occlusion. Disabling deficits are deficits that, if unchanged, would prevent the subject from performing basic activities of daily living (i.e., bathing, ambulating, toileting, hygiene, and eating) or returning to work.
• NIHSS 4-24, or NIHSS 2-24 for patients with aphasia and/or hemianopia.
• Perfusion lesion (Tmax >4.0 seconds) volume ≥10 cc on CTP or MR PWI within the territory of the anterior cerebral artery (ACA) segments, a non-dominant or co-dominant M2 middle cerebral artery (MCA) segment, an M3 MCA, or the posterior cerebral artery (PCA) segments.
• Occluded distal vessel diameter ≥1.5 mm as measured on CTA or MRA.
• Ischemic core lesion (rCBF<30% on CTP or ADC <620 on MR DWI) in ≤50% of the perfusion lesion volume.
• Study treatment can be initiated within 24 hours of last known well time (last known time without current stroke symptoms).
• Signed informed consent by patient or legally authorized representative.
• Subject is not eligible for intravenous thrombolysis within 3 hours from stroke onset per FDA label and American Heart Association/American Stroke Association national guidelines. (Note: administration of intravenous thrombolytics should not be avoided or delayed in order to achieve participation in this study.)