Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial

Launched by GRAVITY MEDICAL TECHNOLOGY, INC · Feb 6, 2024

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ClinConnect Summary

The Gravity Stent-Retriever System trial is studying a new device called the Supernova, which is designed to help treat strokes caused by blood clots blocking blood flow to the brain. This trial aims to find out how safe and effective this device is for patients experiencing acute ischemic strokes, which occur when a blood vessel in the brain gets blocked. If you or someone you know has had a stroke and is between the ages of 18 and 85, there may be a chance to participate in this study if certain conditions are met, such as being treated within 24 hours of stroke symptoms and having a specific type of blockage in the brain’s blood vessels.

Participants in this trial will receive treatment with the Supernova device, which works by removing the clot to restore blood flow. Before joining, patients will need to sign a consent form, and their doctors will evaluate their medical history and current health to ensure they meet the eligibility criteria. It's important to note that there are specific reasons that may prevent someone from participating, such as severe high blood pressure or certain other medical conditions. Overall, this trial represents an opportunity for patients to potentially benefit from an innovative approach to stroke treatment while contributing to important medical research.

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Eligibility criteria

• Inclusion Criteria:
• • 1. New focal neurologic deficit consistent with being of acute cerebral ischemia origin.
• • 2. Age 18-85 years old (inclusive).
• • 3. Interventionalists estimate that treatment with the Supernova (first deployment in target vessel) can be achieved within 24 hours of symptom onset.
• • 4. 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.
• • 5. Admission NIH Stroke Scale score of 8-25
• • 6. No known significant pre-stroke disability (pre-stroke mRS 0 or 1).
• • 7. 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.
• 8. For strokes in the anterior circulation, the following imaging criteria should also be met:
• • 1. MRI criterion: volume of diffusion restriction visually assessed ≤50 mL, OR
• • 2. CT criterion: ASPECTS 6 to 10 on baseline NCCT
• • 9. Anticipated life expectancy of at least 6 months.
• • 10. A signed informed consent by the patient or a Legally Authorized Representative or independent physician in case of oral consent.
• Exclusion Criteria:
• • 1. Subject already participating in another study of an investigational treatment device or treatment.
• • 2. Use any other intra-arterial recanalization drug or device prior to the use of Supernova (Supernova is not the first-choice device).
• • 3. Angiographically evident excessive arterial tortuosity precluding device access to the thrombus.
• • 4. 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.
• • 5. Glucose \< 50 mg/dl (2.78 mmol/L) or \> 400 mg/dl (22.20 mmol/L).
• • 6. Known hemorrhagic diathesis.
• • 7. Coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 3.0.
• • 8. Treatment with heparin within 48 h with a partial thromboplastin time more than two times the laboratory normal.
• • 9. Patients who have received a direct thrombin inhibitor within the last 48 hours; must have a partial thromboplastin time (PTT) less than 1.5 times the normal to be eligible.
• • 10. Platelet count of less than 50,000/ µL.
• • 11. History of severe allergy to contrast medium, nickel, or Nitinol.
• • 12. Intracranial hemorrhage.
• • 13. Significant mass effect with midline shift.
• • 14. Intracranial tumor (apart from small meningioma, ≤ 2 cm in diameter).
• • 15. Stenosis or any occlusion in the deployment site or in a proximal vessel requiring treatment or preventing device access to the thrombus (for example, stenosis or occlusion in the cervical internal carotid artery or common carotid artery).
• • 16. Presence of intracranial atherosclerotic disease requiring rescue therapy (for example, intracranial stenting).
• • 17. Females who are pregnant or breastfeeding.
• • 18. Known current use of narcotic drugs at the time of treatment.
• • 19. Prior recent stroke in the past 3 months.
• • 20. Renal failure with serum creatinine \>3.0 or Glomerular Filtration Rate (GFR) \<30.
• • 21. Known cerebral vasculitis.
• • 22. Rapidly improving neurological status defined as the improvement of greater than 8 points on the NIHSS or improvement to NIHSS of \< 6 prior to the procedure.
• • 23. Clinical symptoms are suggestive of bilateral stroke or stroke in multiple territories.
• • 24. Ongoing seizure due to stroke.
• • 25. Evidence of active systemic infection.
• • 26. Known cancer with metastases.
• • 27. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
• • 28. Evidence of dissection in the extra or intracranial cerebral arteries.
• • 29. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation or anterior/posterior circulation).
• • 30. Aneurysm in the target vessel.