Phase
Condition
Stroke
Blood Clots
Thrombosis
Treatment
Conventional thrombectomy device treatment group
Super-Bore Thrombosis Aspiration Catheter treatment group
Super-Bore 8F Thrombosis Aspiration Catheter treatment group
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 theinternal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA),or the basilar artery (with or without involvement of the intracranial vertebralartery) 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 qualifiedrepresentative.
Exclusion
Exclusion Criteria:
Pregnant or lactating women;
Severe allergic reactions to contrast agents;
Current participation in other clinical studies;
Known hereditary or acquired bleeding disorders, platelet count <50,000/µL, orcoagulation factor deficiencies;
Renal failure with serum creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) <30mL/min;
Expected survival < 6 months or known cancer with metastases;
Clinical manifestations suggesting subarachnoid hemorrhage, despite normal CT or MRIfindings;
Suspected aortic dissection;
Known arterial condition in a proximal vessel that requires treatment or preventsaccess to the site of occlusion or safe recovery of the investigational device (forexample, severe stenosis, complete occlusion in the cervical ICA, tandem occlusion);
High degree of suspicion of intracranial arterial disease (ICAD), such as evidenceof multifocal ICAD on CTA, MRA, or DSA, or any other finding that is highlysuggestive of ICAD as the underlying etiology of the occlusion;
Evidence of dissection in the extracranial or intracranial cerebral arteries;
Intracranial hemorrhage on CT or MRI;
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;
Pre-existing neurological or psychiatric disease that would confound theneurological or functional evaluation, e.g., dementia with prescribedanti-cholinesterase inhibitor;
Clinical history, past imaging or clinical judgement suggest that the intracranialocclusion is chronic;
Excessive vascular access tortuosity or target vessel size that will likely preventendovascular access with the Super-Bore Aspiration Catheters;
Intracranial stent implanted in the same vascular territory that would preclude thesafe 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 clinicalevidence of bilateral strokes or strokes in multiple territories as determined bythe treating physician;
Known aneurysm at or near the target treatment segment;
Known glucose level< 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L);
Patients who, in the opinion of the investigator, are unsuitable for mechanicalthrombectomy as evidenced by imaging findings.
Study Design
Connect with a study center
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
ChinaActive - Recruiting

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