Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated With Neurothrombectomy Devices in India

Korábbi kezelés

• Concurrent participation in another mechanical neurothrombectomy device trial or any other clinical trial with an active treatment arm or where the study procedure or treatment might confound the study analysis

Egyéb

• Patients meeting the contraindication as mentioned in the IFU of devices.
• Significant mass effect with midline shift

• Subject/subject's legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements
• Subject is 18 years of age or older
• Subject has experienced an Acute Ischemic Stroke due to large intracranial vessel occlusion in at least one of the following intracranial vessels: internal carotid artery (ICA), M1 and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral arteries
• Subject has been or will be treated with a Medtronic market-released neuro thrombectomy device as the initial device used to remove the thrombus
• Subject is willing to participate in a 90-day follow-up visit
• Treatment within 24 hours of last known well. For subjects with stroke onset >6 hours:
  • ASPECTS score >5 (per DW-MRI) or >6 (per NCCT)
  • NCCT Core Infarct < 70 ml or MRI DWI with < 70 ml core volume or CTP Ratio of volume of ischemic tissue (penumbra) to infarction of ≥1.8 and an absolute volume of potentially reversible ischemia of ≥15ml
• Pre-Stroke Modified Rankin Scale (mRS) score ≤1 (immediately) prior to stroke onset
• Pre-treatment National Institutes of Health Stroke Scale (NIHSS)
  • ≥6 and ≤30 for patients with ≤6 hours of stroke onset.
  • ≥10 and ≤30 for patients with >6 hours of stroke onset.