Post Market Multi-Center Retrospective Research on Embolization of Intracranial Aneurysms With Pipeline Embolization Device in China
NCT ID: NCT03831672
Last Updated: 2019-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2018-11-01
2019-06-30
Brief Summary
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Detailed Description
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A number of multi-center clinical studies on Pipeline embolization devices (PED, Ev3 Company/Medtronic, USA) have been conducted in North America and Europe recently. Becske etc reported the result of one multi-center prospective clinical trial of North America (PUFS), the PED treats the complicated intracranial internal carotid artery aneurysm. At the time of 180 days, 1 year, 3 years follow-up, the complete occlusion rate were 73.6%, 86.8% and 93.4% respectively. O 'kelly etc. the study showed that the rate of subtotal occlusion over 1 year follow-up of PED treatment for complex intracranial aneurysms was 90%. Many studies have confirmed the effectiveness of PED in the treatment of complex intracranial aneurysms.
The main motivation to innovate the blood flow diverter device is to use it to treat some large or giant aneurysms, fusiform aneurysm which can't be treated well by ordinary interventional embolization methods. So, in the initial stage of the application, its indications are mainly focus on the large or giant aneurysms located in the internal carotid artery before the origin of the posterior communicating artery. In recent years, the blood flow diverter devices were already used to treat many kinds of IA in almost all parts of the brain, different sizes and with pathological changes, such as dissecting aneurysms and vesicular aneurysms.
Although there was already much clinical research evidence which proved the efficacy and safety of PipelineTM 's treatment to the aneurysm as the embolization device, but these data are all from the foreign population, there is still no published clinical evidence of large sample size clinical study of Chinese population. Pipeline has been widely used to treat large width IA. Therefore, it's meaningful to evaluate effectiveness and safety in Chinese population, and this may guide the clinical practice and meet the clinical needs better.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients treated with Pipeline
Exclusion Criteria
* Patients treated by other stent
* Patients lacking 3-dimensional aneurysm images or the images not satisfied the simulation
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Henan Provincial People's Hospital
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Group of Brain Doctors
UNKNOWN
Peking University International Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
Qilu Hospital of Shandong University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
RenJi Hospital
OTHER
Second Affiliated Hospital of Nanchang University
OTHER
Beijing Neurosurgical Institute
OTHER
Responsible Party
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Xinjian Yang, MD
Vice Chair of Department of Interventional Neuroradiology
Principal Investigators
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Xinjian Yang, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Locations
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Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Zhang Y, Zhang F, Turhon M, Huang J, Li M, Peng Q, Zheng Z, Liu J, Zhang Y, Liu J, Zhang H, Li T, Song D, Zhao Y, Aisha M, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Guan S. Treatment of Intracranial Vertebral Artery Dissecting Aneurysms Using Pipeline Embolization Devices : A Multicenter Cohort Study. Clin Neuroradiol. 2023 Dec;33(4):1105-1114. doi: 10.1007/s00062-023-01318-7. Epub 2023 Jun 28.
Zhao Y, Lu J, Zhang H, Li T, Song D, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J, Zhao Y. Pipeline Embolization Device for intracranial aneurysms presenting with mass effect: a large Chinese cohort. Stroke Vasc Neurol. 2024 Feb 27;9(1):50-58. doi: 10.1136/svn-2022-002213.
Lu J, Zhao Y, Zhang H, Li T, Song D, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J, Zhao Y. Learning curve in pipeline embolization device: results from the pipeline embolization device in China post-market multicentre registry study. Int J Surg. 2023 Aug 1;109(8):2159-2167. doi: 10.1097/JS9.0000000000000467.
Zhang H, Li L, Zhang H, Liu J, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Luo B, Shao Q, Chang K, Zhang Q, He Y, Zhang P, Yang X, Li TX. Small and Medium-Sized Aneurysm Outcomes Following Intracranial Aneurysm Treatment Using the Pipeline Embolization Device: A Subgroup Analysis of the PLUS Registry. Front Neurol. 2022 May 31;13:881353. doi: 10.3389/fneur.2022.881353. eCollection 2022.
Xu C, Wu P, Han J, Sun B, Wang C, Xu S, Luo B, Yang X, Mu Q, Shi H. Safety Evaluation and Flow Modification in the Anterior Cerebral Artery after Pipeline Embolization Device Deployment across the Internal Carotid Artery Terminus. Biomed Res Int. 2021 Aug 21;2021:6657595. doi: 10.1155/2021/6657595. eCollection 2021.
Kang H, Luo B, Liu J, Wang A, Zhang H, Li T, Song D, Zhao Y, Guan S, Wang Y, Feng W, Wang Y, Shi H, Liu J, Yang X. A novel score for evaluating cerebral aneurysms treated with flow diversion: 4F-flow diversion predictive score. Ther Adv Neurol Disord. 2021 Aug 19;14:17562864211039336. doi: 10.1177/17562864211039336. eCollection 2021.
Kang H, Zhou Y, Luo B, Lv N, Zhang H, Li T, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J. Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis. Neurotherapeutics. 2021 Apr;18(2):1198-1206. doi: 10.1007/s13311-020-00990-8. Epub 2021 Jan 14.
Luo B, Kang H, Zhang H, Li T, Liu J, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X. Pipeline Embolization device for intracranial aneurysms in a large Chinese cohort: factors related to aneurysm occlusion. Ther Adv Neurol Disord. 2020 Nov 2;13:1756286420967828. doi: 10.1177/1756286420967828. eCollection 2020.
Other Identifiers
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KY2018-098-01
Identifier Type: -
Identifier Source: org_study_id
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