Evaluating a new catheter for treating severe strokes

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

This study tests if a new type of catheter can help people with severe strokes recover better than the usual treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of University of Science and Technology of China (other)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06559475 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to assess the safety and effectiveness of the Super-Bore 8/7F aspiration catheters in patients experiencing acute intracranial large vessel occlusion due to ischemic stroke. Participants will be randomly assigned to receive either the new catheter or a conventional thrombectomy device. The study focuses on patients who can undergo mechanical thrombectomy within 24 hours of stroke onset and have specific occlusion characteristics confirmed by angiography. The goal is to determine if the new catheter improves outcomes compared to standard treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with acute ischemic stroke who meet specific clinical and imaging criteria.

Not a fit: Patients who are pregnant, have severe allergies to contrast agents, or are currently participating in other clinical studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from acute ischemic strokes.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in improving outcomes for acute ischemic stroke treatments.

Eligibility criteria

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 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;
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 qualified representative.

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, or coagulation factor deficiencies;
5. Renal failure with serum creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) \<30 mL/min;
6. Expected survival \< 6 months or known cancer with metastases;
7. Clinical manifestations suggesting subarachnoid hemorrhage, despite normal CT or MRI findings;
8. Suspected aortic dissection;
9. 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);
10. 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;
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 the neurological or functional evaluation, e.g., dementia with prescribed anti-cholinesterase inhibitor;
16. Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic;
17. Excessive vascular access tortuosity or target vessel size that will likely prevent endovascular access with the Super-Bore Aspiration Catheters;
18. Intracranial stent implanted in the same vascular territory that would preclude the safe 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 clinical evidence of bilateral strokes or strokes in multiple territories as determined by the 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 mechanical thrombectomy as evidenced by imaging findings.

Where this trial is running

Hefei, Anhui

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China (RECRUITING)

Study contacts

• Study coordinator: Wei Hu, MD, PhD

Conditions: Acute Ischemic Stroke, Endovascular Thrombectomy, Super-Bore 8F Thrombosis Aspiration Catheter, Acute Intracranial Large Vessel Occlusion