Brain Diseases, Central Nervous System Diseases, Cerebrovascular Disorders, Ischemic Stroke, Nervous System Diseases, Stroke, Vascular Disease
Conditions
Keywords
Mechanical Thrombectomy, Brain, Brain Clot, Cerebral Ischemia, Brain Infarction, Neurovascular Intervention, Revascularization, Reperfusion, Stent Retriever, Supernova, Stroke, Gravity Medical Technology
Brief summary
Supernova and Neutron are endovascular mechanical revascularization devices indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing an acute ischemic stroke within 24 hours of symptom onset or from last known well time.
Interventions
Mechanical Thrombectomy
Sponsors
Gravity Medical Technology, INC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. 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), M1and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral artery. 2. Subject has been or will be treated with Supernova and/or Neutron devices as the initial device used to remove the thrombus 3. Subject is willing to participate in a 90-day follow-up visit.
Exclusion criteria
* Concurrent participation in another mechanical neurothrombectomy device trial or any other clinical trial with an active treatment arm where the study procedure or treatment might confound the results of the registry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful reperfusion | Day 0 (end of procedure) | Rate of successful reperfusion, defined as modified Thrombolysis in Cerebral Ischemia (mTICI) grade of 2b or higher Grade 0: No reperfusion Grade 3: Complete reperfusion |
| Symptomatic intracranial hemorrhage | sICH measured within 24 (18-36) hours of the procedure | Safety (Rate of symptomatic intracranial hemorrhage (sICH) as measured by the SITS-MOST criteria) The SITS-MOST definition of SICH is a local or remote type II parenchymal haemorrhage within 22 to 36 hours after treatment (or sooner) associated with a ≥ fourpoint deterioration on the NIHSS score from baseline or from the lowest score from baseline to 24 hours, or leading to death. |
| All-cause mortality | All-cause mortality measured at 90 (±14) days | Safety (All-cause mortality) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with a modified Rankin Scale (mRS) score of ≤2 | 90 (±14) days post-treatment | Effectiveness (The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with 0 being perfect health without symptoms to 6 being death. Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead) |
| Asymptomatic Intracranial Hemorrhage | Day 1 (within 24 hours (18-36 hours) of the procedure) | Incidence of any asymptomatic intracranial hemorrhage post-procedure |
| Neurological Deterioration | Day 1 (within 24 hours (18-36 hours) of the procedure) | Safety (defined as a ≥4-point increase in the National Institutes of Health Stroke Scale (NIHSS) score) |
Outcome results
None listed