Distal Ischemic Stroke Treatment with Adjustable Low-profile Stentriever
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Primary Distal Vessel Occlusion
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Age: Between 18 Year(s) - 85 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
- 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.
- 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.
- Participant is not eligible for intravenous thrombolysis within 3 hours from stroke onset per FDA label and American Heart Association/American Stroke Association national guidelines.
You may not be eligible for this study if the following are true:
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- Use of any other intra-arterial (IA) recanalization device prior to the Tigertriever 13 in the target vessel, including aspiration catheter.
- The DVO is a secondary distal occlusion that occurred during a large vessel occlusion (LVO) thrombectomy procedure.
- Prior stroke in the last 3 months.
- Anticipated inability to obtain 3-month follow-up assessments.
- Females who are pregnant or breastfeeding.
- Renal failure.
- Pre-procedural severe sustained hypertension with SBP >220 and/or DBP >120.
- Pre-procedural glucose <50 mg/dl (2.78 mmol/L) or >400 mg/dl (22.20 mmol/L).
- Treatment with heparin within 48 hours with a partial thromboplastin time more than two times the laboratory normal.
- Treatment with a direct oral anticoagulant (DOAC) within 48 hours.
- History of severe allergy to contrast medium, nickel, or Nitinol.
- 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)
- Ongoing seizure due to stroke.
- Evidence of active systemic infection.
- Known cancer with metastases.
- Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
- Participant is already participating in another study of an investigational treatment device or treatment.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.