NCT06559475招募中不适用
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
The First Affiliated Hospital of University of Science and Technology of China1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2024年12月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- The Rates of First Pass Effect (eTICI2c-3)
研究概览
简要总结
To Evaluate the Safety and Efficacy of the Super-Bore 8/7F Thrombosis Aspiration Catheter in the Treatment of Acute Intracranial Large Vessel Occlusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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, or coagulation factor deficiencies;
- •Renal failure with serum creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) <30 mL/min;
- •Expected survival < 6 months or known cancer with metastases;
- •Clinical manifestations suggesting subarachnoid hemorrhage, despite normal CT or MRI findings;
- •Suspected aortic dissection;
- •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);
- •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;
- •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 the neurological or functional evaluation, e.g., dementia with prescribed anti-cholinesterase inhibitor;
- •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;
- •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 mechanical thrombectomy as evidenced by imaging findings.
研究组 & 干预措施
Super-Bore Thrombosis Aspiration Catheter treatment group
Experimental
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.
干预措施: Super-Bore Thrombosis Aspiration Catheter treatment group (Procedure)
Conventional thrombectomy device treatment group
Active Comparator
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.
干预措施: Conventional thrombectomy device treatment group (Procedure)
结局指标
主要结局
The Rates of First Pass Effect (eTICI2c-3)
时间窗: Within 5 minutes at final angiography of thrombectomy
Evaluate effect of thrombectomy on reperfusion
次要结局
- Proportion of mRS 0-2 at 90 days(90 (± 14 days) after procedure)
- 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (Ordinal Shift Analysis);(90 (± 14 days) after procedure)
研究者
Wei Hu
Professor
The First Affiliated Hospital of University of Science and Technology of China
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Single-Arm Objective Performance Criteria Trial for Intracranial Thrombus Aspiration CatheterAcute Ischemic StrokeNCT05119647Zhuhai Tonbridge Medical Tech. Co., Ltd.124
暂停
不适用
CLEANer Aspiration for Pulmonary EmbolismCardiovascular DiseasesPulmonary EmbolismVenous ThromboembolismAcute Pulmonary EmbolismNCT06189313Argon Medical Devices125
Unknown
4 期
Thrombus Aspiration in Patients With STEMIST-segment Elevation Myocardial InfarctionNCT02606435Xijing Hospital300
已完成
不适用
Thrombectomy Revascularization of Intracranial Vessel OcclusioN by Originating From Japan (TRON1-Japan)Acute Ischemic StrokeNCT02964702JIMRO Co., Ltd.50
尚未招募
不适用
Investigating Efficacy and Safety of JETi® in Arterial Occlusions in FEM-POP and Prox BTK-Lesions (JETART)Peripheral Arterial DiseaseNCT06434779Vascular Science LP GmbH200