Clinical trial NCT03831672: Post Market Multi-Center Retrospective Research on Embolization of Intracranial Aneurysms With Pipeline Embolization Device in China
Official title: Post Market Multi-Center Retrospective Research on Embolization of Intracranial Aneurysms With Pipeline Embolization Device in China (PLUS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Aneurysm
Pipeline Embolization Device
Keywords: intracranial aneurysm
outcome
occlusion
Pipeline embolization device
endovascular treatment
flow diversion
Lead sponsor: Beijing Neurosurgical Institute
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
name: Henan Provincial People's Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Group of Brain Doctors
name: Peking University International Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: First Affiliated Hospital of Xinjiang Medical University
name: Qilu Hospital of Shandong University
name: Nanfang Hospital, Southern Medical University
name: The First Affiliated Hospital of Nanchang University
name: RenJi Hospital
name: Second Affiliated Hospital of Nanchang University
First posted: 2019-02-06
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: Recent years, the rapid development of endovascular treatment, especially the introduction of blood flow diverter device, has led to a new step in the treatment of intracranial aneurysms. It is different from usual treatment concept, blood flow diverter device's innovation is guiding to its parent artery reconstruction by cutting into the blood flow velocity and flow rate to the IA, and, promote the forming of aneurysm cavity thrombosis and the Neointima growth of IA's neck, so that to achieve aneurysm treatment.

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.

Eligibility criteria: Inclusion Criteria:

* Patients accepting to participate the study
* Patients treated with Pipeline

Exclusion Criteria:

* Patients treated by parent vessel occlusion
* Patients treated by other stent
* Patients lacking 3-dimensional aneurysm images or the images not satisfied the simulation

Primary outcomes:
measure: Rate of complete aneurysm occlusion in 12 months
timeFrame: assessed at 12 months (plus or minus 3 months) after procedure
measure: Occurrence of ipsilateral major stroke or neurovascular death in 12 months
timeFrame: assessed at 12 months (plus or minus 3 months) after procedure
Secondary outcomes:
measure: Rate of Complete aneurysm occlusion in 6 months
timeFrame: assessed at 6 months (plus or minus 3 months) after procedure
measure: Rate of Complete aneurysm occlusion in 24 months
timeFrame: assessed at 24 months (plus or minus 6 months) after procedure
measure: Occurrence of ipsilateral major stroke or neurovascular death in 1 month
timeFrame: assessed at 1 month (plus or minus 0.5 month) after procedure
measure: Device-related neurologic adverse event in 12 months
timeFrame: assessed at 12 months (plus or minus 3 months) after procedure
measure: Occurrence of ipsilateral major stroke or neurovascular death in 24 months
timeFrame: assessed at 24 months (plus or minus 6 months) after procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Neurosurgical Institute and Beijing Tiantan Hospital
name: Xinjian Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.