Tests a clot suction catheter for stroke caused by a large brain artery blockage
Compares a new suction catheter with standard devices in adults with acute ischemic stroke.
Key facts
- Who runs it
- The First Affiliated Hospital of University of Science and Technology of China
- Where
- Hefei, ChinaSee the site
- Trial code
- Registry title
- 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
- Status
- Recruiting
- People taking part
- 360 people, planned
- Started
- 16 Dec 2024
- Planned end
- 1 Apr 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Super-Bore Thrombosis Aspiration Catheter treatment group
- Conventional thrombectomy device treatment group
- Record updated
- 18 December 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a sudden stroke caused by a blocked large brain artery, who can have a clot-removal procedure within 24 hours.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Acute ischemic stroke with a complete or near-complete blockage (eTICI 0-1) of the internal carotid artery, the M1 segment of the middle cerebral artery, or the basilar artery, confirmed by angiography. NIHSS score of 6 or greater. ASPECTS or PC-ASPECTS score of 6-10. Vessel diameter of 2.2 mm or more at the blockage.
- Earlier treatment
- Must be able to have mechanical thrombectomy within 24 hours of onset. Before the stroke, the mRS score was 0 or 1.
Main reasons for not taking part
- Pregnant or breastfeeding women
- Bleeding in the brain on CT or MRI
- Severe kidney failure (creatinine 3 mg/dL (265 µmol/L) or higher, or GFR below 30 mL/min)
- Known bleeding disorder or platelet count below 50,000/µL
- Expected survival under 6 months or known cancer with metastases
The registry criteria, word for word
Show all 31 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- 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
- 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);
- 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
Where in China
- The First Affiliated Hospital of University of Science and Technology of ChinaHefei, ChinaContact: Wei Hu, MD,PhDTaking people
About the trial
What the trial wants to find out
To Evaluate the Safety and Efficacy of the Super-Bore 8/7F Thrombosis Aspiration Catheter in the Treatment of Acute Intracranial Large Vessel Occlusion.
The 2 groups in the trial
- Super-Bore Thrombosis Aspiration Catheter treatment groupTreatment being tested
For the subjects randomized to the Super-Bore Thrombosis Aspiration Catheter treatment group, mechanical thrombectomy will be performed using a Super-Bore 8/7F Thrombosis Aspiration Catheter.
- Conventional thrombectomy device treatment groupExisting treatment, for comparison
For the subjects randomized to the conventional thrombectomy device treatment group, mechanical thrombectomy will be performed using a commonly used thrombectomy devices in clinic, except for Super-Bore 8/7F Thrombosis Aspiration Catheter.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Tests a clot suction catheter for stroke caused by a large brain artery blockageGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 18 December 2024