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

Exclusion Criteria30

• 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.
• 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.
• Glucose < 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L).
• Known hemorrhagic diathesis.
• Coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 3.0.
• Treatment with heparin within 48 h with a partial thromboplastin time more than two times the laboratory normal.
• 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.
• Platelet count of less than 50,000/ µL.
• History of severe allergy to contrast medium, nickel, or Nitinol.
• Intracranial hemorrhage.
• Significant mass effect with midline shift.
• Intracranial tumor (apart from small meningioma, ≤ 2 cm in diameter).
• 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).
• Presence of intracranial atherosclerotic disease requiring rescue therapy (for example, intracranial stenting).
• Females who are pregnant or breastfeeding.
• Known current use of narcotic drugs at the time of treatment.
• Prior recent stroke in the past 3 months.
• Renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30.
• Known cerebral vasculitis.
• 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.
• Clinical symptoms are suggestive of bilateral stroke or stroke in multiple territories.
• Ongoing seizure due to stroke.
• Evidence of active systemic infection.
• Known cancer with metastases.
• Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
• Evidence of dissection in the extra or intracranial cerebral arteries.
• Occlusions in multiple vascular territories (e.g., bilateral anterior circulation or anterior/posterior circulation).
• Aneurysm in the target vessel.