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

Last updated: December 14, 2024
Sponsor: The First Affiliated Hospital of University of Science and Technology of China
Overall Status: Active - Recruiting

Phase

N/A

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

NCT06559475
Super Aspiration
  • Ages > 18
  • All Genders

Study Summary

To Evaluate the Safety and Efficacy of the Super-Bore 8/7F Thrombosis Aspiration Catheter in the Treatment of Acute Intracranial Large Vessel Occlusion.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18 years or older;

  2. Clinical presentation consistent with acute ischemic stroke (AIS);

  3. Able to receive mechanical thrombectomy within 24 hours of onset;

  4. Pre-morbid mRS score of 0 or 1;

  5. Baseline NIHSS score of 6 or greater;

  6. 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;

  7. Vessel diameter ≥2.2 mm at the occlusion site;

  8. ASPECTS or PC-ASPECTS score of 6-10 on NCCT, CTA-source imaging, or DWI-MRI;

  9. Written informed consent obtained from the patient or the patient's qualifiedrepresentative.

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating women;

  2. Severe allergic reactions to contrast agents;

  3. Current participation in other clinical studies;

  4. Known hereditary or acquired bleeding disorders, platelet count <50,000/µL, orcoagulation factor deficiencies;

  5. Renal failure with serum creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) <30mL/min;

  6. Expected survival < 6 months or known cancer with metastases;

  7. Clinical manifestations suggesting subarachnoid hemorrhage, despite normal CT or MRIfindings;

  8. Suspected aortic dissection;

  9. 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);

  10. 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;

  11. Evidence of dissection in the extracranial or intracranial cerebral arteries;

  12. Intracranial hemorrhage on CT or MRI;

  13. Evidence of intracranial mass effect or tumor (except small meningiomas defined as ≤ 3cm and asymptomatic)) on CT or MRI;

  14. Suspicious of cerebral vasculitis or infectious endocarditis;

  15. Pre-existing neurological or psychiatric disease that would confound theneurological or functional evaluation, e.g., dementia with prescribedanti-cholinesterase inhibitor;

  16. Clinical history, past imaging or clinical judgement suggest that the intracranialocclusion is chronic;

  17. Excessive vascular access tortuosity or target vessel size that will likely preventendovascular access with the Super-Bore Aspiration Catheters;

  18. Intracranial stent implanted in the same vascular territory that would preclude thesafe deployment/removal of the thrombectomy devices;

  19. 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;

  20. Known aneurysm at or near the target treatment segment;

  21. Known glucose level< 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L);

  22. Patients who, in the opinion of the investigator, are unsuitable for mechanicalthrombectomy as evidenced by imaging findings.

Study Design

Total Participants: 360
Treatment Group(s): 3
Primary Treatment: Conventional thrombectomy device treatment group
Phase:
Study Start date:
December 16, 2024
Estimated Completion Date:
April 01, 2026

Connect with a study center

  • The First Affiliated Hospital of University of Science and Technology of China

    Hefei, Anhui
    China

    Active - Recruiting

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