Post Market Multi-Center Retrospective Research on Embolization of Intracranial Aneurysms With Pipeline Embolization Device in China
PLUS
1 other identifier
observational
200
1 country
1
Brief Summary
Pipeline TM embolization device launched to China in 2014, and has been widely used to treat large width IA. Therefore, it is necessary to collect and analysis the clinical data to evaluate effectiveness and safety of its usage in Chinese population, and this may guide the clinical practice and meet the clinical needs better.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2018
CompletedFirst Submitted
Initial submission to the registry
January 28, 2019
CompletedFirst Posted
Study publicly available on registry
February 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedFebruary 11, 2019
February 1, 2019
8 months
January 28, 2019
February 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of complete aneurysm occlusion in 12 months
Complete occlusion defined as no contrast in contact with the IA neck or with the wall of the IA sac
assessed at 12 months (plus or minus 3 months) after procedure
Occurrence of ipsilateral major stroke or neurovascular death in 12 months
Including but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy
assessed at 12 months (plus or minus 3 months) after procedure
Secondary Outcomes (5)
Rate of Complete aneurysm occlusion in 6 months
assessed at 6 months (plus or minus 3 months) after procedure
Rate of Complete aneurysm occlusion in 24 months
assessed at 24 months (plus or minus 6 months) after procedure
Occurrence of ipsilateral major stroke or neurovascular death in 1 month
assessed at 1 month (plus or minus 0.5 month) after procedure
Device-related neurologic adverse event in 12 months
assessed at 12 months (plus or minus 3 months) after procedure
Occurrence of ipsilateral major stroke or neurovascular death in 24 months
assessed at 24 months (plus or minus 6 months) after procedure
Eligibility Criteria
The trial is intended to conduct in 13 centers in China. The sample size of this study was calculated based on the embolization rate of aneurysm. According to the existing overseas research data, we assume that the one-year embolization rate of Pipeline treatment for aneurysms is about 70%. Under the condition that the allowable error is 10% and the inspection level is 0.05, 162 cases are needed in this study. Considering the heterogeneity of different centers, the further expanded sample size is 200 cases.
You may qualify if:
- Patients accepting to participate the study
- Patients treated with Pipeline
You may not qualify if:
- Patients treated by parent vessel occlusion
- Patients treated by other stent
- Patients lacking 3-dimensional aneurysm images or the images not satisfied the simulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Neurosurgical Institutelead
- Xuanwu Hospital, Beijingcollaborator
- Henan Provincial People's Hospitalcollaborator
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- Group of Brain Doctorscollaborator
- Peking University International Hospitalcollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- First Affiliated Hospital of Xinjiang Medical Universitycollaborator
- Qilu Hospital of Shandong Universitycollaborator
- Nanfang Hospital, Southern Medical Universitycollaborator
- The First Affiliated Hospital of Nanchang Universitycollaborator
- RenJi Hospitalcollaborator
- Second Affiliated Hospital of Nanchang Universitycollaborator
Study Sites (1)
Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100050, China
Related Publications (8)
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.
PMID: 37380901DERIVEDZhao 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.
PMID: 37295810DERIVEDLu 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.
PMID: 37158157DERIVEDZhang 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.
PMID: 35711259DERIVEDXu 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.
PMID: 34471639DERIVEDKang 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.
PMID: 34434256DERIVEDKang 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.
PMID: 33447904DERIVEDLuo 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.
PMID: 33224273DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xinjian Yang, MD
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Chair of Department of Interventional Neuroradiology
Study Record Dates
First Submitted
January 28, 2019
First Posted
February 6, 2019
Study Start
November 1, 2018
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
February 11, 2019
Record last verified: 2019-02