Treatment With Intent to Generate Endovascular Reperfusion
Tigertriever is a CE marked mechanical revascularization device indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment. The objective of the TIGER Study is to evaluate the safety and effectiveness of the Tigertriever device in restoring blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke due to a large vessel occlusion (LVO). This study is designed to support substantial equivalence to approved and marketed products such as the Solitaire or Trevo Retriever.
• New focal neurologic deficit consistent with being of acute cerebral ischemia origin.
• Age 18-85 years old (inclusive).
• Interventionalist estimates that treatment with the Tigertriever (first deployment in target vessel) can be achieved within 8 hours of symptom onset.
• Patient either: a) eligible for, and received, IV t-PA within 3 hours of symptom onset, at the correct 0.9 mg/kg dose, or b) ineligible for IV t-PA.
• NIH Stroke Scale score of 8-29.
• No known significant pre-stroke disability (prestroke mRS 0 or 1).
• Catheter angiographic confirmation of a large vessel occlusion in the intracranial internal carotid artery, the M1 or M2 segments of the middle cerebral artery, the intracranial vertebral artery, or the basilar artery that is accessible to Tigertriever device.
• For strokes in the anterior circulation, the following imaging criteria should also be met:
∙ MRI criterion: volume of diffusion restriction visually assessed ≤50 mL, OR
‣ CT criterion: ASPECTS 6 to 10 on baseline NCCT or CTA-source images,
• For strokes in the posterior circulation, the following imaging criterion should also be met: pcASPECTS score 8 to 10 on baseline NCCT, CTA-source images, or DWI MRI.
⁃ Anticipated life expectancy of at least 6 months.
⁃ A signed informed consent by patient or a Legally Authorized Representative or independent physician in case of oral consent.