Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment (SENAT)
2013年5月31日 更新者：Stryker Neurovascular
This is a prospective observational multicenter registry to evaluate safety and efficacy data on Neuroform3TM stenting for treatment with endovascular coiling of wide neck aneurysms on an intent to treat basis.
The objectives of this study are:
- Assessment of morbidity-mortality at 1 month and 12-18 months following the treatment of the intracranial aneurysm with Neuroform3TM stent and endovascular coiling using the modified Rankin scale (mRS).
- to evaluate adverse events.
- Angiographic assessment at 12-18 months compared to the initial post-treatment assessment via the modified Raymond scale and same/better/worse scale.
研究概览
详细说明
There is an increasing perception in the Neurovascular community - supported by extensive peer-to-peer and congress communications - that "stent-assisted coiling" of intracranial wide neck aneurysms improves the long term angiographic outcome of treated patients.
研究类型
观察性的
注册 (实际的)
116
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Bordeaux、法国、33076
- Centre Hospitalier pellegrin
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Caen、法国、14033
- CHU Hôpital de la Côte de Nacre
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Lille、法国、59037
- CHRU Salengro
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Limoges、法国、87042
- CHU Limoges
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Lyon、法国、69394
- Hôpital neurologique
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Montpellier、法国、34059
- Hôpital Gui de Chauliac
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Nancy、法国、54035
- CHU Nancy
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Nantes、法国、44035
- CHU Hôpital Guillaume et René Laënnec
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Nice、法国、06000
- Hôpital Saint-Roch
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Paris、法国、75010
- Hôpital Lariboisière
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Paris、法国、75013
- Groupe Hospitalier Pitie-Salpetriere
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Paris、法国、75019
- Fondation Rotschild
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Patient coming to the hospital to get an endovascular treatment of the aneurysm
描述
Inclusion Criteria:
- 18 year's old patient or above.
- every patient suffering from an un-ruptured or ruptured aneurysm, for whom the endovascular treatment approach using the Neuroform3TM stent is considered by the therapeutic team in charge.
- patient who has given his consent to participate to the study and to get his anonymized data collected
Exclusion Criteria:
- patient with dissecting or fusiform aneurysm
- treatment of several aneurysms in the same procedure, except adjacent aneurysm treated by the same stent
- severe vasospasm
- aneurysm associated with an arterio-venous malformation
- use of another Neuroform3TM stent
- woman pregnant or nursing
- patients not likely to be followed upon (living abroad)
- people protected by justice (safeguard of law, supervision or trusteeship)
- patient unsuitable to the anti-thrombotic and/or to anticoagulants therapies
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Morbidity and Mortality associated with stenting and coiling
大体时间：30 days and 12-18 months post procedure
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Assessment of morbidity and mortality at 30 days and 12-18 months post endovascular treatment of wide neck aneurysm with a Neurform 3 stent and coiling as assessed by the modified Rankin scale (mRS).
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30 days and 12-18 months post procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Efficacy of the Neuroform stent for treatment of wide neck aneurysms
大体时间：post procedure and at 12-18 months post procedure
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Assessment of the morphological results post endovascular coiling and stenting of wide neck aneurysms and assessment of anatomical stability of the treatment at 12-18 months post procedure
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post procedure and at 12-18 months post procedure
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Alessandra Biondi
- 首席研究员：Alain Bonafé
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Murayama Y, Nien YL, Duckwiler G, Gobin YP, Jahan R, Frazee J, Martin N, Vinuela F. Guglielmi detachable coil embolization of cerebral aneurysms: 11 years' experience. J Neurosurg. 2003 May;98(5):959-66. doi: 10.3171/jns.2003.98.5.0959.
- Leung CH, Poon WS, Yu LM; International Subarachnoid Aneurysm Trial. The ISAT trial. Lancet. 2003 Feb 1;361(9355):430-1; author reply 432. doi: 10.1016/s0140-6736(03)12405-1. No abstract available.
- Akpek S, Arat A, Morsi H, Klucznick RP, Strother CM, Mawad ME. Self-expandable stent-assisted coiling of wide-necked intracranial aneurysms: a single-center experience. AJNR Am J Neuroradiol. 2005 May;26(5):1223-31.
- Alfke K, Straube T, Dorner L, Mehdorn HM, Jansen O. Treatment of intracranial broad-neck aneurysms with a new self-expanding stent and coil embolization. AJNR Am J Neuroradiol. 2004 Apr;25(4):584-91.
- Barath K, Cassot F, Rufenacht DA, Fasel JH. Anatomically shaped internal carotid artery aneurysm in vitro model for flow analysis to evaluate stent effect. AJNR Am J Neuroradiol. 2004 Nov-Dec;25(10):1750-9.
- Benitez RP, Silva MT, Klem J, Veznedaroglu E, Rosenwasser RH. Endovascular occlusion of wide-necked aneurysms with a new intracranial microstent (Neuroform) and detachable coils. Neurosurgery. 2004 Jun;54(6):1359-67; discussion 1368. doi: 10.1227/01.neu.0000124484.87635.cd.
- Byrne JV, Bashiri M, Pasco A, Morris JH. A novel flexible endovascular stent for use in small and tortuous vessels. Neuroradiology. 2000 Jan;42(1):56-61. doi: 10.1007/s002340050015.
- Canton G, Levy DI, Lasheras JC, Nelson PK. Flow changes caused by the sequential placement of stents across the neck of sidewall cerebral aneurysms. J Neurosurg. 2005 Nov;103(5):891-902. doi: 10.3171/jns.2005.103.5.0891.
- dos Santos Souza MP, Agid R, Willinsky RA, Cusimano M, Montanera W, Wallace MC, terBrugge KG, Marotta TR. Microstent-assisted coiling for wide-necked intracranial aneurysms. Can J Neurol Sci. 2005 Feb;32(1):71-81. doi: 10.1017/s0317167100016917.
- Fiorella D, Albuquerque FC, Han P, McDougall CG. Preliminary experience using the Neuroform stent for the treatment of cerebral aneurysms. Neurosurgery. 2004 Jan;54(1):6-16; discussion 16-7. doi: 10.1227/01.neu.0000097194.35781.ea.
- Howington JU, Hanel RA, Harrigan MR, Levy EI, Guterman LR, Hopkins LN. The Neuroform stent, the first microcatheter-delivered stent for use in the intracranial circulation. Neurosurgery. 2004 Jan;54(1):2-5. doi: 10.1227/01.neu.0000099370.05758.4d. No abstract available.
- Lylyk P, Ferrario A, Pasbon B, Miranda C, Doroszuk G. Buenos Aires experience with the Neuroform self-expanding stent for the treatment of intracranial aneurysms. J Neurosurg. 2005 Feb;102(2):235-41. doi: 10.3171/jns.2005.102.2.0235.
- Wakhloo AK, Lanzino G, Lieber BB, Hopkins LN. Stents for intracranial aneurysms: the beginning of a new endovascular era? Neurosurgery. 1998 Aug;43(2):377-9. doi: 10.1097/00006123-199808000-00126. No abstract available.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年7月1日
初级完成 (实际的)
2010年9月1日
研究完成 (实际的)
2010年12月1日
研究注册日期
首次提交
2009年6月23日
首先提交符合 QC 标准的
2009年6月24日
首次发布 (估计)
2009年6月25日
研究记录更新
最后更新发布 (估计)
2013年6月4日
上次提交的符合 QC 标准的更新
2013年5月31日
最后验证
2013年5月1日
更多信息
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