Safety and Efficacy of Endovascular Treatment for Acute Basilar Artery Occlusion in the Extended Time Window -a Prospective, Multicenter, Randomized Controlled, Open-label Clinical Trial

A prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial to evaluate the safety and efficacy of endovascular mechanical thrombectomy for acute basilar artery occlusion in the extended time window

开始日期2024-09-10

申办/合作机构

首都医科大学

NCT06489925 / Not yet recruiting早期临床1期IIT

Cerebrolysin as an Add-On Therapy to Standard Treatment of Posterior Circulation Stroke Secondary to Basilar Artery Occlusion

The standard therapy for acute ischemic posterior circulation stroke (PCS) often leads to poor functional outcomes and high mortality rates, despite all advances in reperfusion therapy. Recent trials have shown that adding Cerebrolysin, a cerebral neuroprotective agent, to standard therapy for patients with acute ischemic anterior circulation stroke is safe and leads to improved functional outcomes. The purpose of this study is to assess the effectiveness and safety of Cerebrolysin with standard treatment for patients with PCS secondary to basilar artery occlusion (BAO).
The plan is to conduct a prospective, single-center, single-arm, open-label study with 20 acute basilar artery occlusion patients and premorbid modified Rankin Score (mRS) ≤3, treated with standard treatment (mechanical thrombectomy ± intravenous alteplase or conservative treatment) and Cerebrolysin as add-on therapy, compared with historical controls. Besides standard acute stroke assessment, standard treatment, and rehabilitation, the participants who meet the eligibility criteria will receive Cerebrolysin in a single-day dosage of 30 ml intravenously for 14 consecutive days. The participants will be closely monitored, and neuroimaging findings and clinical outcomes will be obtained during the drug administration period, on discharge, one month, and 3 months after the treatment onset.
The primary endpoints are mRS (0-3) on day 90 and mortality rate 90 days after the stroke onset. The secondary endpoints are defined as a change in any type of intracerebral bleeding and a change of min. 2 points on the National Institutes of Health Stroke Scale 24 hours, 14 days, 30 days, and 90 days post-stroke.
The investigators hypothesize that adding Cerebrolysin to standard stroke treatment will improve clinical outcomes and reduce morbidity and mortality in patients with acute basilar occlusion compared to standard treatment alone.

开始日期2024-07-01

申办/合作机构

EVER Neuro Pharma GmbH

ChiCTR2400082236 / SuspendedN/AIIT

Follow-up Study on the Safety and Efficacy of Endovascular Treatment for Acute Basilar Artery Occlusion

开始日期2024-03-28

申办/合作机构-

100 项与基底动脉闭塞相关的临床结果

登录后查看更多信息

100 项与基底动脉闭塞相关的转化医学

登录后查看更多信息

0 项与基底动脉闭塞相关的专利（医药）

登录后查看更多信息

1,793

项与基底动脉闭塞相关的文献（医药）

2024-12-01·Journal of Stroke and Cerebrovascular Diseases

The prognostic impact of malnutrition on the outcomes of patients with vertebrobasilar artery occlusion following endovascular treatment

Article

作者: Jia, Zhenyu ; Cao, Yue-zhou ; Shi, Hai-bin ; Pan, Song ; Cao, Yue-Zhou ; Sun, Wen ; bo Zhao, Lin- ; Shi, Hai-Bin ; Liu, Dezhi ; Zhao, Lin-Bo ; Liu, Sheng

BACKGROUND AND PURPOSEMalnutrition is associated with poor outcomes in different diseases. Our aim was to investigate whether measures of malnutrition could be used to predict 90-day outcomes in patients with vertebrobasilar artery occlusion (VBAO) undergoing endovascular treatment (EVT).METHODSWe retrospectively analyzed patients with VBAO who received EVT at three comprehensive stroke centers. Malnutrition was assessed using the controlling nutritional status (CONUT) score, geriatric nutritional risk index (GNRI), and prognostic nutritional index (PNI). Primary outcome was good functional outcome defined as modified Rankin Scale (mRS) 0-3 measured at 90 days.RESULTSA total of 285 patients were enrolled, of which 260 (91.22 %) met the requirements. According to the CONUT, GNRI, and PNI scores, the proportions of patients classified as moderately or severely malnourished were 7.3 %, 3.08 %, and 35 %, respectively. In the multivariate regression model after adjusting for potential confounders, malnutrition (severe risk versus normal nutritional status) was significantly associated with an increased risk of poor prognosis for CONUT scores (adjusted odds ratio [OR]14.91, 95 %CI, 1.69 - 131.71; P = 0.015), GNRI scores (adjusted [OR] 10.67, 1.17 - 96.93; P = 0.036) and PNI scores (adjusted [OR] 4.61, 2.28 - 9.31; P < 0.001). Similar results were obtained when malnutrition scores were analyzed as continuous variables. Adding the 3 malnutrition measures to the risk reclassification that included traditional risk factors significantly improved the predictive value of 3-month poor prognosis.CONCLUSIONSOur study showed that malnutrition may be associated with poor prognosis within 3 months of EVT in patients with VBAO.

2024-12-01·Radiology Case Reports

Successful mechanical thrombectomy with an aspiration catheter for fenestrated basilar artery occlusion guided by preoperative basi-parallel anatomical scanning

Article

作者: Hanaya, Ryosuke ; Shigehatake, Yuya ; Sato, Masanori ; Miyashita, Fumio ; Hosoyama, Hiroshi ; Tokimura, Hiroshi ; Nishimuta, Yosuke

Basilar artery (BA) fenestration and its occlusion are relatively rare conditions. Mechanical thrombectomy for fenestrated BA occlusion has a high risk of complications. One limb occlusion or partial occlusion of fenestration mimics arterial stenosis or dissection. We present the case of a 75-year-old woman who presented with slight dysarthria, which subsequently worsened. Magnetic resonance imaging, magnetic resonance angiography, and basi-parallel anatomical scanning (BPAS) revealed BA fenestration and occlusion of the larger limb of the fenestrated BA, for which we performed thrombectomy with aspiration and achieved Thrombolysis in Cerebral Infarction Grade 3 flow restoration without procedure-related complications. If BA occlusion occurs at a site where a thrombus does not normally occur, confirming the anatomy of the BA before thrombectomy is desirable. As we obtained information on BA fenestration and occluded limb diameter using preoperative BPAS, we were able to safely achieve effective recanalization by guiding a relatively large-diameter aspiration catheter to the thrombus coaxially with a micro-guidewire and microcatheter.

2024-12-01·Journal of Stroke and Cerebrovascular Diseases

Repeated basilar tip occlusion associated with atlantooccipital assimilation: A case report

Article

作者: Numazawa, Shinichi ; Kawamata, Takakazu ; Yoshida, Hirotaka ; Morita, Shuhei ; Mori, Kentaro ; Ootomo, Tomoko ; Watanabe, Sadayoshi

We describe an 82-year-old man with multiple cerebral infarctions due to vertebral artery dissection associated with an atlanto-occipital assimilation. Despite multiple thrombectomies and antithrombotic therapy changes, the patient developed thrombosis and recurrent infarction, due to mechanical damage to the vertebral artery possibly associated with abnormal cervical spine motion from atlanto-occipital assimilation. This case highlights the rare association between atlanto-occipital assimilation and stroke and the importance of considering structural abnormalities for stroke management.

项与基底动脉闭塞相关的新闻（医药）

2024-10-16

·梅斯医学

《柳叶刀》重磅综述：中风急救，发病24小时患者也可从血管内治疗中获益

颅内大动脉闭塞性（LVO）卒中指累及颈内动脉（ICA）、大脑中动脉（MCA）、椎动脉（VA）、基底动脉（BA）等部位的急性闭塞，约占所有缺血性卒中的20%，具有高病死率、高致残率的特点。单纯静脉溶栓治疗LVO再通率低，而血管内治疗，即动脉溶栓、机械取栓和桥接取栓（静脉溶栓后机械取栓）可显著提高再通率，改变了颅内大动脉闭塞性（LVO）卒中患者的治疗模式。起初研究发现相比于药物治疗，血管内治疗可降低患者残疾，且核心梗死较小、发病时间窗为6小时的患者更能从治疗中受益。当前，已有相关证据证实，发病时间窗为24小时、大面积缺血性核心梗死和基底动脉闭塞患者也可从血管内治疗中获益。此外，学术界还在探索血管内治疗前静脉溶栓是否对LVO患者有益、治疗LVO的接触抽吸技术效果是否更佳等等。近日，《柳叶刀》（The Lancet）发表综述，阐述了当前急性卒中血管内管理的进展，以期为临床实践提供参考。截图来源：The Lancet 不同类型LVO的治疗情况小核心梗死、早期时间窗（6小时内）几项随机临床试验结果显示，对于前循环近端LVO和中重度卒中患者，治疗3个月时，相比于药物治疗，血管内治疗可降低残疾几率。每3例患者接受血管内治疗，就有1例患者治疗后3个月避免发生残疾。MR CLEAN研究证实，前循环近端LVO卒中发病6小时内患者，采用血管内治疗可从中受益。小核心梗死、晚期时间窗（6~24小时）目前，血管内治疗被认为可使6~24小时时间窗的患者获益。DAWN试验结果显示，对于症状发作在6~24小时内出现临床影像学不匹配（患者临床症状严重，但影像学显示脑损伤范围较小，可能并不需要进行灌注成像）的前循环LVO患者，相比于药物治疗，血管内治疗与更高功能独立性（mRS 0~2分：49% vs. 13%）和更低的残疾发生率相关。DEFUSE 3试验则发现，在症状发作6~16小时内出现前循环LVO伴灌注成像不匹配的患者，接受血管内治疗的患者，90天mRS结局更佳，功能独立性明显改善。主要指南均提出，需要借助先进的成像方式，如CT灌注和MRI来选择晚期窗口期患者。大核心梗死 24小时时间窗内，前循环大面积缺血性核心卒中患者约占所有患者的10%~15%。再灌注出血和恶性脑水肿进展，一直是大面积缺血患者再灌注的核心关注要点。既往有6项大型试验，对不同纳入标准患者和成像方式进行探索，整体来看，6项试验均支持对24小时窗口期内具有较大核心梗死的患者，采用血管内治疗。基底动脉闭塞（BAO） BAO是最早被临床认识的综合征之一，对BAO的治疗探索推动了急性脑卒中动脉溶栓治疗的发展。BAO症状表现较多，患者可出现以下任一症状或多个症状，如构音障碍、吞咽困难、颅神经缺损、感觉缺损、偏瘫和闭锁综合征等。从既往RCT荟萃分析结果来看，大多数中重度BAO患者接受血管内治疗是有利的，而轻度功能缺损的患者能否获益临床证据尚不充足。静脉溶栓 or 血管内治疗？既往在LVO患者急性卒中血管内治疗获益的经典试验中，均对符合溶栓条件的患者采取了静脉溶栓。因此，相关指南建议在血管内治疗前先静脉溶栓。但对于可直接到血管内治疗中心接受治疗的患者，这一治疗模式的价值受到临床挑战。一方面，尽管静脉溶栓+血管内治疗可能增加整体介入治疗后再灌注率，但其疗效随着时间延长而下降，且介入前再灌注率不足；另一方面，全球范围内溶栓药物种类不足也增加了临床对治疗方式的关注。 6项临床随机试验显示，在4.5小时时间窗内，对于LVO卒中、无静脉溶栓禁忌证、直接就诊于血管内治疗中心的患者，大多数患者单独采用血管内治疗疗效非劣效于静脉溶栓。对于在具有机械取栓能力的卒中中心就诊的患者而言，相比于单独机械取栓，静脉溶栓联合机械取栓的治疗效果更具有时间依赖性，早期治疗显示出更大的治疗获益。但如果在不具备血管内治疗的医院就诊时，LVO患者应接受静脉溶栓治疗。随着替奈普酶使用的增加，相比于阿替普酶，患者从治疗中获益的可能会更高。小结总之，在过去的十几年间，对于LVO卒中患者的治疗和护理有着显著的变化。临床试验数据的更新、血管内治疗器械和技术的进步、血管内治疗适应证的扩展，以及血管内治疗成像技术的发展，都提高了临床治疗LVO卒中的疗效和安全性。参考资料 [1] Nguyen TN, Abdalkader M, Fischer U, Qiu Z, Nagel S, Chen HS, Miao Z, Khatri P. Endovascular management of acute stroke. Lancet. 2024 Sep 28;404(10459):1265-1278. doi: 10.1016/S0140-6736(24)01410-7. PMID: 39341645. [2] 中国研究型医院学会介入神经病学专业委员会.中国急性大动脉闭塞性卒中介入治疗技术策略专家共识[J]. 中华内科杂志, 2023, 62(8): 931-938. DOI: 10.3760/cma.j.cn112138-20220819-00608. 撰文 | 医学新视点编辑 | 阿拉斯加宝 ●Nature重磅：饭吃“六分饱”和间歇性禁食能延寿，但是要付出代价的！谷歌旗下抗衰老研究公司最新发文 ●哀悼！近期两名顶级科主任突然离世！享年均为59岁！15岁考上大学、天才医生、风湿免疫专家、糖尿病防治大咖！我们无比惋惜悲痛 ●深度热议！病人进了手术室，医生索要3000元“专家费”，不给不做手术？卫健委回应！近3成医生飞刀过，说不清的飞刀，该如何面对？版权说明：梅斯医学（MedSci）是国内领先的医学科研与学术服务平台，致力于医疗质量的改进，为临床实践提供智慧、精准的决策支持，让医生与患者受益。欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。点击下方「阅读原文」立刻下载梅斯医学APP！

临床结果临床研究