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Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal staging with 'Minimally-Invasive Segmental Artery Coil-Embolization' (MISACE): A Randomized Controlled Multicentre Trial (PAPA_ARTiS)

Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal staging with 'Minimally-Invasive Segmental Artery Coil-Embolization' (MISACE): A Randomized Controlled Multicentre Trial (PAPA_ARTiS)
通过胸腹分期和“微创节段动脉线圈栓塞”(MISACE)预防主动脉瘤修复中的截瘫:随机对照多中心试验(PAPA_ARTiS)
批准号:
316656770
负责人:
Professor Dr. Christian Etz
金额:
$0.0万
依托单位国家:
德国
项目类别:
Clinical Trials
财政年份:
--
资助国家:
德国
项目状态:
未结题
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中文摘要
翻译
慢性主动脉瘤是主动脉的永久性和局限性扩张,在很长一段时间内保持无症状,但在最终破裂之前直径不断增大。如果不进行治疗,患者的预后是惨淡的,因为破裂的内出血会导致猝死。虽然成功的治疗治愈了这种疾病,但危险的手术方式严重而永久地损害了脊髓的血液供应,经常导致截瘫,特别是涉及关键节段动脉的动脉瘤,即Crawford II和III型胸腹主动脉瘤。虽然各种治疗策略已经显著降低了截瘫的发生率,但仍不低于10%-20%。然而,首席研究员团队最近发现,故意将节段性动脉闭塞到最终供应脊髓的棘旁侧支网络可以触发动脉侧支,从而稳定替代流入来源的血液供应,防止缺血。这转化为一种临床上可用的治疗方案,即“微创节段性动脉圈栓塞术”(MISACE),它以“分期”的方式在高度可控的条件下闭塞多组动脉,之后,必须为动脉生成留出时间,以建立强大的侧枝供血。Papa-Artis是一项试验,旨在证明分期治疗方法,即在根治性动脉瘤治疗之前选择性闭塞节段动脉,可以显著减少截瘫和死亡率。
英文摘要
Chronic aortic aneurysms are permanent and localized dilations of the aorta that remain asymptomatic for long periods of time, but continue to increase in diameter before they eventually rupture. Left untreated, the patients’ prognosis is dismal, since the internal bleeding of the rupture brings about sudden death. Although successful treatment cures the disease, the risky procedures compromise spinal cord blood supply acutely and permanently, frequently leading to paraplegia, particularly for aneurysms involving crucial segmental arteries, i.e. thoracoabdominal aortic aneurysms of Crawford type II & III. Although various strategies have achieved a remarkable decrease in the incidence of paraplegia, it is still no less than 10-20%. However, the principal investigator’s team has recently found that the deliberate staged occlusion of the segmental arteries to the paraspinous collateral network finally supplying the spinal cord can trigger arterial collateralization, thus stabilizing blood supply from alternate inflow sources and preventing ischaemia. This translated to a clinically available therapeutic option, ‘minimally invasive segmental artery coil embolization’ (MISACE), which proceeds in a ‘staged’ manner to occlude groups of arteries under highly controlled conditions, after which, time must be allowed for arteriogenesis to build a robust collateral blood supply. PAPA-ARTiS is a trial to demonstrate that a staged treatment approach, selectively occluding segmental arteries prior to curative aneurysm treatment, can reduce paraplegia and mortality dramatically.
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