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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supernova revascularization device | Experimental | Mechanical thrombectomy with Supernova Stent Retriever |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supernova revascularization device | Device | Mechanical Thrombectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful reperfusion | 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 | Day 0 (end of procedure) |
| Symptomatic intracranial hemorrhage | 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. | sICH measured within 24 (18-36) hours of the procedure |
| All-cause mortality | Safety (All-cause mortality) | All-cause mortality measured at 90 (±14) days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with a modified Rankin Scale (mRS) score of ≤2 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002545 | Brain Ischemia |
| D020520 | Brain Infarction |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
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| 90 (±14) days post-treatment |
| Asymptomatic Intracranial Hemorrhage | Incidence of any asymptomatic intracranial hemorrhage post-procedure | Day 1 (within 24 hours (18-36 hours) of the procedure) |
| Neurological Deterioration | Safety (defined as a ≥4-point increase in the National Institutes of Health Stroke Scale (NIHSS) score) | Day 1 (within 24 hours (18-36 hours) of the procedure) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |