A Multicenter, Randomized Controlled Clinical Investigation to Evaluate the Safety and Effectiveness of the Super-Bore 8/7F Aspiration Catheters in the Treatment of Acute Intracranial Large Vessel Occlusion

Korábbi kezelés

• Known arterial condition in a proximal vessel that requires treatment or prevents access to the site of occlusion or safe recovery of the investigational device (for example, severe stenosis, complete occlusion in the cervical ICA, tandem occlusion);

Más betegség

• Severe allergic reactions to contrast agents;
• Expected survival < 6 months or known cancer with metastases;
• Clinical manifestations suggesting subarachnoid hemorrhage, despite normal CT or MRI findings;
• High degree of suspicion of intracranial arterial disease (ICAD), such as evidence of multifocal ICAD on CTA, MRA, or DSA, or any other finding that is highly suggestive of ICAD as the underlying etiology of the occlusion;
• Intracranial hemorrhage on CT or MRI;
• Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluation, e.g., dementia with prescribed anti-cholinesterase inhibitor;

Laborértékek

• Known hereditary or acquired bleeding disorders, platelet count <50,000/µL, or coagulation factor deficiencies;
• Renal failure with serum creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) <30 mL/min;
• Known glucose level< 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L)；

Egyéb

• Pregnant or lactating women;
• Current participation in other clinical studies;
• Suspected aortic dissection;
• Evidence of dissection in the extracranial or intracranial cerebral arteries;
• Evidence of intracranial mass effect or tumor (except small meningiomas defined as ≤ 3cm and asymptomatic)) on CT or MRI;
• Suspicious of cerebral vasculitis or infectious endocarditis;
• Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic;
• Excessive vascular access tortuosity or target vessel size that will likely prevent endovascular access with the Super-Bore Aspiration Catheters;
• Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the thrombectomy devices;
• Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior circulation/vertebrobasilar system) as confirmed on CTA/MRA, or clinical evidence of bilateral strokes or strokes in multiple territories as determined by the treating physician;
• Known aneurysm at or near the target treatment segment;
• Patients who, in the opinion of the investigator, are unsuitable for mechanical thrombectomy as evidenced by imaging findings.

• Aged 18 years or older;
• Clinical presentation consistent with acute ischemic stroke (AIS);
• Able to receive mechanical thrombectomy within 24 hours of onset;
• Pre-morbid mRS score of 0 or 1;
• Baseline NIHSS score of 6 or greater;
• Complete or near-complete occlusion (eTICI 0-1) of the intracranial segment of the internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or the basilar artery (with or without involvement of the intracranial vertebral artery) confirmed by angiography who can undergo intravascular thrombectomy;
• Vessel diameter ≥2.2 mm at the occlusion site;
• ASPECTS or PC-ASPECTS score of 6-10 on NCCT, CTA-source imaging, or DWI-MRI;
• Written informed consent obtained from the patient or the patient's qualified representative.