Post Market Multi-Center Retrospective Research on Embolization of Intracranial Aneurysms With Pipeline Embolization Device in China (PLUS)

Post Market Multi-Center Retrospective Research on Embolization of Intracranial Aneurysms With Pipeline Embolization Device in China (PLUS)

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.

Study Overview

• Status: Unknown
• Conditions: Intracranial Aneurysm; Pipeline Embolization Device

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University
      • Contact: Jian Liu, MD; Phone Number: +86-010-59978852; Email: jianliu_ns@163.com
      • Contact: Xinjian Yang, MD; Phone Number: +86-010-59978852; Email: yangxinjian@bjttyy.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Complete aneurysm occlusion in 6 months	Complete occlusion defined as no contrast in contact with the IA neck or with the wall of the IA sac	assessed at 6 months (plus or minus 3 months) after procedure
Rate of Complete aneurysm occlusion in 24 months	Complete occlusion defined as no contrast in contact with the IA neck or with the wall of the IA sac	assessed at 24 months (plus or minus 6 months) after procedure
Occurrence of ipsilateral major stroke or neurovascular death in 1 month	Including but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy	assessed at 1 month (plus or minus 0.5 month) after procedure
Device-related neurologic adverse event 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
Occurrence of ipsilateral major stroke or neurovascular death in 24 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 24 months (plus or minus 6 months) after procedure

Collaborators and Investigators

• Sponsor: Beijing Neurosurgical Institute
• Collaborators: The First Affiliated Hospital of Nanchang University; RenJi Hospital; Qilu Hospital of Shandong University; Nanfang Hospital of Southern Medical University; Xuanwu Hospital, Beijing; Peking University International Hospital; The First Affiliated Hospital of Zhengzhou University; Henan Provincial People's Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; First Affiliated Hospital of Xinjiang Medical University; Second Affiliated Hospital of Nanchang University; Group of Brain Doctors
• Investigators: Principal Investigator: Xinjian Yang, MD, Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ANTICIPATED): June 30, 2019
• Study Completion (ANTICIPATED): June 30, 2019

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: February 2, 2019
• First Posted (ACTUAL): February 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: outcome; endovascular treatment; occlusion; intracranial aneurysm; flow diversion; Pipeline embolization device
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: KY2018-098-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No