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 .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Mechanical Thrombectomy
Marengo CIMS Hospital
Ahmedabad, Gujarat, India
P.D. Hinduja Hospital and Medical Research Centre
Mumbai, Maharashtra, India
Dr Balabhai Nanavati Hospital
Mumbai, Maharashtra, India
All India Institute of Medical Sciences, New Delhi
New Delhi, National Capital Territory of Delhi, India
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, Puducherry, India
Yashoda Hospitals, Secunderabad
Hyderabad, Telangana, India
Yashoda Hospitals, Somajiguda
Hyderabad, Telangana, India
Apollo Hospitals
Hyderabad, Telangana, India
The Calcutta Medical Research Institute
Kolkata, West Bengal, India
Tehran University of Medical Sciences
Tehran, Tehran Province, Iran
...and 1 more locations
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
Time frame: 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.
Time frame: sICH measured within 24 (18-36) hours of the study procedure
All-cause mortality
Safety (All-cause mortality)
Time frame: All-cause mortality measured at 90 (±14) days
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)
Time frame: 90 (±14) days post-treatment
Successful Reperfusion at First Pass
Effectiveness (Successful reperfusion defined as mTICI 2b or better at first pass)
Time frame: Assessed at first pass of the intervention during the procedure
Asymptomatic Intracranial Hemorrhage
Safety (Incidence of any asymptomatic intracranial hemorrhage post-procedure)
Time frame: 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)
Time frame: Day 1 (within 24 hours (18-36 hours) of the procedure)
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