Actively Recruiting
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
Led by The First Affiliated Hospital of University of Science and Technology of China · Updated on 2024-12-18
360
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Super-Bore 8/7F Thrombosis Aspiration Catheter in treating acute intracranial large vessel occlusion, a serious type of acute ischemic stroke. This randomized controlled trial compares this new catheter with commonly used thrombectomy devices to see which is better at removing blood clots and restoring blood flow in the brain. Participants are randomly assigned to one of two groups: one group receives mechanical thrombectomy using the Super-Bore 8/7F Thrombosis Aspiration Catheter, while the other group is treated with standard thrombectomy devices. The procedure is performed within 24 hours of stroke onset to remove the clot blocking major brain arteries. During the study, researchers will measure how often the first pass effect (successful clot removal on the first attempt) occurs within 5 minutes at the final angiography. They will also assess participants’ disability and recovery 90 days after the procedure using the modified Rankin Score. Participants will be monitored closely throughout to evaluate safety, treatment impact, and outcomes.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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), M1 segment of the middle cerebral artery (MCA), or basilar artery confirmed by angiography
- 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 from patient or qualified representative
You will not qualify if you...
- Pregnant or lactating women
- Severe allergic reactions to contrast agents
- Current participation in other clinical studies
- Known bleeding disorders, platelet count <50,000/5L, or coagulation factor deficiencies
- Renal failure with serum creatinine 3 mg/dL or GFR <30 mL/min
- Expected survival <6 months or known metastatic cancer
- Clinical signs suggesting subarachnoid hemorrhage despite normal CT or MRI
- Suspected aortic dissection
- Arterial conditions preventing safe device access or retrieval
- High suspicion of intracranial arterial disease (ICAD)
- Evidence of cerebral artery dissection
- Intracranial hemorrhage on CT or MRI
- Intracranial mass effect or tumor larger than 3cm or symptomatic
- Suspicion of cerebral vasculitis or infectious endocarditis
- Neurological or psychiatric disease that may affect evaluation
- Chronic intracranial occlusion
- Excessive vascular access difficulty or vessel size preventing device use
- Intracranial stent in treatment area precluding device use
- Multiple vascular territory occlusions
- Known aneurysm near treatment site
- Blood glucose level <50 mg/dl or >400 mg/dl
- Investigator judged unsuitable for mechanical thrombectomy based on imaging
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours from symptom onset
Participants receive mechanical thrombectomy using either the Super-Bore 8/7F Thrombosis Aspiration Catheter or a conventional thrombectomy device.
1 procedure visit
Duration - Approximately 90 days
Participants are followed for recovery and assessment of functional outcomes after the thrombectomy procedure.
1 follow-up visit around 90 days after procedure
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Actively Recruiting
Research Team
W
Wei Hu, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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