NCT05615038进行中（未招募）不适用
A Comparison of Contact Aspiration Versus Stent Retriever for Acute Basilar Artery Occlusion: A Multicentre, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial
Beijing Tiantan Hospital6 个研究点 分布在 1 个国家目标入组 338 人开始时间: 2022年11月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 338
- 试验地点
- 6
- 主要终点
- Rate of first pass effect (FPE)
研究概览
简要总结
Compare the effectiveness and safety of contact aspiration (CA) and stent retriever (SR) in acute ischemic stroke patients with basilar artery 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
- None
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
- •Age≥18 years;
- •Acute basilar artery occlusion confirmed by CTA/MRA/DSA;
- •Last known well to puncture time≤24 hours;
- •pc-ASPECTS score≥6 points;
- •Baseline NIHSS score≥10 points;
- •Consent to endovascular treatment;
- •Informed consent signed.
排除标准
- •Baseline mRS≥3 points;
- •Known or suspected severe basilar artery stenosis (>70%) or chronic occlusion based on history, imaging, or clinical manifestations;
- •Refractory hypertension that is difficult to be controlled by drugs (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg)
- •Genetic or acquired hemorrhagic tendency, coagulation factor deficiency or on anticoagulant therapy and International Normalized Ratio (INR) > 3.0;
- •Laboratory tests: baseline blood glucose <50mg/dl (2.8mmol/L) or >400mg/dl (22.2mmol/L); Baseline platelet count <50×109/L;
- •Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications;
- •Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test;
- •Other circumstances that the investigator considers inappropriate for participation in the trial or that may pose significant risks to patients (such as inability to understand and/or follow the study procedures and/or follow up due to mental disorders, cognitive or emotional disorders).
- •Imaging Exclusion Criteria:
- •CT or MR evidence of acute intracranial hemorrhage (the presence of microbleeds on MRI is allowed);
- •Midline shift or herniation, mass effect with effacement of the ventricles;
- •Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the 4-th ventricle;
- •Complete bilateral thalamic infarction on CT or MRI;
- •Inability to endovascular treatment due to Excessive tortuosity, variation, or dissection of the artery;
- •Subjects with occlusions in both intracranial vertebral arteries;
- •Subjects with occlusions in both anterior and posterior circulation;
- •Evidence of intracranial tumor (except small meningioma).
结局指标
主要结局
Rate of first pass effect (FPE)
时间窗: 24 hours
\[The definition of FPE: 1) single pass/use of the device; 2)recanalization of the large vessel occlusion to eTICI 2C/3;3) no use of rescue therapy.\]
次要结局
- The difference of NIHSS score between 24-hour and baseline(24 hours)
- Rate of complete reperfusion (eTICI 3) after first-line thrombectomy strategy and at the end of endovascular procedure(24 hours)
- Rate of near to complete reperfusion (eTICI 2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure(24 hours)
- Rate of successful reperfusion (eTICI 2b/2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure(24 hours)
- Rate of mRS 0-2 at at 90±14 days(90 days)
- Rate of mRS 0-3 at at 90±14 days(90 days)
- Rate of any intracranial hemorrhage within 48 hours (according to Heidelberg Bleeding Classification)(48 hours)
- All cause of mortality at 90±14 days(90 days)
- Rate of Arterial Occlusive Lesion (AOL) recanalization score 3 after first-line thrombectomy strategy and at the end of endovascular procedure(24 hours)
- Groin puncture time to successful reperfusion time (min)(24 hours)
- Modified Rankin Score (mRS) at 90±14 days (shift analysis)(90 days)
- Rate of mRS 0-1 at at 90±14 days(90 days)
- Quality of life at 90±14 days assessed by EuroQol 5D-5L scale(90 days)
- Rate of symptomatic intracranial hemorrhage within 48 hours (according to Heidelberg Bleeding Classification)(48 hours)
- Rate of procedure-related complications, included arterial dissection, embolization in a new territory, arterial perforation and subarachnoid haemorrhage(24 hours)
研究者
Zhongrong Miao
Director of Interventional Neurology
Beijing Tiantan Hospital
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Combined Use of Contact Aspiration and the Stent Retriever Technique Versus Stent Retriever Alone for Recanalisation in Acute Cerebral InfarctionAcute Ischemic StrokeNCT03290885Hopital Foch408
Unknown
不适用
COmparing CeNters ThRombectomy Aspiration STentretrieverAcute StrokeNCT03412851Hospitales Universitarios Virgen del Rocío1,000
终止
不适用
Thrombectomy in Patients Ineligible for iv tPAIschemic StrokeNCT02135926University Hospital Heidelberg4
进行中（未招募）
不适用
Comparison of Stent retriever and Intra-arterial fibrinolysis in patients with acute ischemic strokeDiseases of the nervous systemKCT0000860Yonsei University Health System, Severance Hospital119
已完成
不适用
Thrombectomy In ANdalucia Using Aspiration (TRIANA)Stroke, AcuteNCT03407092Hospitales Universitarios Virgen del Rocío532