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The study aims to evaluate the safety and efficacy of the Supernova stent retriever device, developed by Gravity Medical Technology, for treating acute ischemic stroke. The device is used to remove blood clots and restore blood flow to the brain .
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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 study 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:
New focal neurologic deficit consistent with being of acute cerebral ischemia origin.
Age 18-85 years old (inclusive).
Interventionalists estimate that treatment with the Supernova (first deployment in target vessel) can be achieved within 24 hours of symptom onset.
Intravenous thrombolysis may be given as per national guidelines and patients receiving or not receiving intravenous thrombolysis will both be eligible for inclusion in the study.
Admission NIH Stroke Scale score of 8-25
No known significant pre-stroke disability (pre-stroke mRS 0 or 1).
Catheter angiographic confirmation of large vessel occlusion in the intracranial internal carotid artery, the M1 or M2 segments of the middle cerebral artery, or the basilar artery that is accessible to the Supernova device.
For strokes in the anterior circulation, the following imaging criteria should also be met:
Anticipated life expectancy of at least 6 months.
A signed informed consent by the patient or a Legally Authorized Representative or independent physician in case of oral consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dileep R. Yavagal, MD, MBBS | University of Miami & Jackson Memorial Hospitals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marengo CIMS Hospital | Ahmedabad | Gujarat | 380060 | India | ||
| P.D. Hinduja Hospital and Medical Research Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41371775 | Derived | Yavagal DR, Gaikwad SB, Vibha D, Narayan SK, Nagarajan K, Kesavarupu SR, Sharma MK, Sharaf R, Vankayalapati S, Mehta A, Das D, Doshi D, Oak P, Salunkhe M, Jankowitz B, Rai AT, Brown SB, Zaidi SF, Asif KS, Liebeskind DS, Jovin TG, Pandian J, Jadhav AP, Atchaneeyasakul K, Desai S, Giragani S; GRASSROOT Trial investigators; GRASSROOT trial investigators GRASSROOT Trial investigators. Mechanical thrombectomy for acute ischemic stroke in a low- and middle-income country: primary outcomes from the GRASSROOT Trial. J Neurointerv Surg. 2025 Dec 10:jnis-2025-024470. doi: 10.1136/jnis-2025-024470. Online ahead of print. |
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| 90 (±14) days post-treatment |
| Successful Reperfusion at First Pass | Effectiveness (Successful reperfusion defined as mTICI 2b or better at first pass) | Assessed at first pass of the intervention during the procedure |
| Asymptomatic Intracranial Hemorrhage | Safety (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) |
| Mumbai |
| Maharashtra |
| 400016 |
| India |
| Dr Balabhai Nanavati Hospital | Mumbai | Maharashtra | 400056 | India |
| All India Institute of Medical Sciences, New Delhi | New Delhi | National Capital Territory of Delhi | 110029 | India |
| Jawaharlal Institute of Postgraduate Medical Education and Research | Puducherry | Puducherry | 605006 | India |
| Yashoda Hospitals, Secunderabad | Hyderabad | Telangana | 500082 | India |
| Yashoda Hospitals, Somajiguda | Hyderabad | Telangana | 500082 | India |
| Apollo Hospitals | Hyderabad | Telangana | 500096 | India |
| The Calcutta Medical Research Institute | Kolkata | West Bengal | 700027 | India |
| Tehran University of Medical Sciences | Tehran | Tehran Province | 1416753955 | Iran |
| National Institute of Cardiovascular Diseases | Karachi | Sindh | 75510 | Pakistan |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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