Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial (NCT06249776) | Clinical Trial Compass
CompletedNot Applicable
Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial
India54 participantsStarted 2024-02-09
Plain-language summary
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 .
Who can participate
Age range18 Years – 85 Years
SexALL
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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:
Exclusion criteria
✕. Subject already participating in another study of an investigational treatment device or treatment.
✕. Use any other intra-arterial recanalization drug or device prior to the use of Supernova (Supernova is not the first-choice device).
✕. Angiographically evident excessive arterial tortuosity precluding device access to the thrombus.
What they're measuring
1
Successful reperfusion
Timeframe: Day 0 (end of procedure)
2
Symptomatic intracranial hemorrhage
Timeframe: sICH measured within 24 (18-36) hours of the study procedure
3
All-cause mortality
Timeframe: All-cause mortality measured at 90 (±14) days
✕. For all patients, severe sustained hypertension with SBP \>220 and/or DBP \>120; for patients treated with IV tPA, sustained hypertension despite treatment with SBP \>185 and/or DBP \> 110.