Sind Ballonassistierte Führungskatheter in Der Endovaskulären Schlaganfalltherapie Der Vorderen Zirkulation überlegen? (BEST-Studie) Guiding Catheters in Endovascular Stroke Therapy - Are Balloon Guided Catheters Superior?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Successful recanalisation
研究概览
简要总结
The BEST study is an academically initiated, single-center, prospective, randomized controlled clinical trial investigating the potential advantages and disadvantages of using a guide catheter with or without a balloon in the interventional treatment of acute ischemic stroke.
The study population consists of adult patients with acute ischemic stroke of the anterior circulation for whom interventional recanalization therapy via catheter is indicated following interdisciplinary consultation between the Department of Neurology and Neuroradiology at Heidelberg University Hospital.
In addition to routine clinical treatment measures and data collection, patients will be interviewed by telephone after 90 days to assess their quality of life and level of independence using standardized scoring systems.
All medical devices used or investigated in this study bear the CE mark (Conformité Européenne ) and will be used within their intended purpose. Study participants will not be subjected to any additional invasive or burdensome procedures beyond normal usage.
详细描述
Are balloon guide catheters in endovascular stroke therapy of the anterior circulation superior? (BEST) Background Meta-analyses on the use of balloon-guided catheters (BGK) suggest a better technical and clinical outcome after endovascular stroke therapy (EST). However, no randomised controlled trials exist to support these results, yet.
Study objective To investigate whether usage of BGK for EST of anterior circulation ischemic stroke due to large vessel occlusion results in improved degree of recanalization of the target vessel and the associated vascular territory.
Study population N = 110 patients (55 per group, 1:1 randomisation) with acute ischemic stroke due to large vessel occlusion of the anterior circulation and intention to treatment with EST.
Inclusion criteria
- Patients with acute ischemic stroke due to large vessel occlusion of the anterior circulation (internal carotid artery-T, M1 (segment of the middle cerebral artery) or proximal M2 (M2 segment of the middle cerebral artery) occlusion) proven by either computed tomography (CT) or magentic resonance imaging (MRI)
- Estimated time between stroke onset / last seen well and study procedure of < 24 hours
- No relevant pre-stroke functional disability (pre-morbid modified Rankin Sacle (mRS) of 0 - 3)
- Neurological deficit with a National Instutute of Health Stroke Scale (NIHSS) of ≥ 4 and ≤ 25
- Age ≥ 18
- Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 on baseline non-contrast CT < 4,5h after onset or CT perfusion / MRI > 4,5h after onset
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
- •Patients with an acute ischemic stroke
- •Location of the primary occlusion in the anterior cerebral circulation
- •Pre-therapeutic modified Rankin Scale (mRS) score of ≤
- •Written informed consent from
- •the patient or
- •their legal representative/guardian or
- •patient enrollment by an independent physician and the principal investigator
排除标准
- •Patients with contraindications to interventional therapy
- •Patients with acute intracranial hemorrhage
- •Pregnancy/Breastfeeding
- •Pre-therapeutic mRS > 3
- •National Institute of Health Stroke Scale (NIHSS) ≤ 4
- •Patients detained in an institution by court or government order
- •Patients who require intubation for treatment
研究组 & 干预措施
Ballon guide catheter
Thrombectomy of an acute ischemic stroke using a balloon-guided catheter
干预措施: Ballon guide catheter (Device)
Guide catheter without balloon
Thrombectomy of an acute ischemic stroke using a guide catheter without balloon
干预措施: Guide catheter without balloon (Device)
结局指标
主要结局
Successful recanalisation
时间窗: up to day 1
expanded treatment in cerebral ischemia (eTICI) Score ≥2c eTICI Grades: grade 0: no perfusion noted (0% reperfusion) grade 1: reduction in thrombus but without any resultant filling of distal arterial branches grade 2A: reperfusion of 1-49% of the territory grade 2B50: reperfusion of 50-66% of the territory grade 2B67: reperfusion of 67-89% of the territory grade 2C: extensive reperfusion of 90-99% of the territory grade 3: complete or full reperfusion (100% reperfusion)
次要结局
- Technical success(Periprocedural)
- Number of Participants with Distal emboli(Periprocedural)
- Infarct growth(up to 48 hours after treatment)
- Number of emboli(Day 1 - 2)
- Modified Rankin Scale(Up to 90 days after treatment)
- 24hr NIHSS(24 Hours after treatment)
- 7d NIHSS(Up tp Day 7 after treatment)
- First-Pass-Effekt, Number of Participants with reperfusion on first pass(Periprocedural)
- Time to visualization(Periprocedural)
- Time to first pass(Periprocedural)
- Time to success(Periprocedural)
- Number of Passes(Periprocedural)
研究者
Michael Breckwoldt
Section Chief Immuno-Imaging Neuroradiology
University Hospital Heidelberg