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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03831672
Acronym
PLUS
Enrollment
200
Registered
2019-02-06
Start date
2018-11-01
Completion date
2019-06-30
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Aneurysm, Pipeline Embolization Device

Keywords

intracranial aneurysm, outcome, occlusion, Pipeline embolization device, endovascular treatment, flow diversion

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.

Interventions

None listed

Sponsors

Xuanwu Hospital, Beijing
CollaboratorOTHER
Henan Provincial People's Hospital
CollaboratorOTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Group of Brain Doctors
CollaboratorUNKNOWN
Peking University International Hospital
CollaboratorOTHER
The First Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
First Affiliated Hospital of Xinjiang Medical University
CollaboratorOTHER
Qilu Hospital of Shandong University
CollaboratorOTHER
Nanfang Hospital, Southern Medical University
CollaboratorOTHER
The First Affiliated Hospital of Nanchang University
CollaboratorOTHER
RenJi Hospital
CollaboratorOTHER
Second Affiliated Hospital of Nanchang University
CollaboratorOTHER
Beijing Neurosurgical Institute
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of complete aneurysm occlusion in 12 monthsassessed at 12 months (plus or minus 3 months) after procedureComplete occlusion defined as no contrast in contact with the IA neck or with the wall of the IA sac
Occurrence of ipsilateral major stroke or neurovascular death in 12 monthsassessed at 12 months (plus or minus 3 months) after procedureIncluding but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy

Secondary

MeasureTime frameDescription
Occurrence of ipsilateral major stroke or neurovascular death in 1 monthassessed at 1 month (plus or minus 0.5 month) after procedureIncluding but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy
Rate of Complete aneurysm occlusion in 6 monthsassessed at 6 months (plus or minus 3 months) after procedureComplete occlusion defined as no contrast in contact with the IA neck or with the wall of the IA sac
Occurrence of ipsilateral major stroke or neurovascular death in 24 monthsassessed at 24 months (plus or minus 6 months) after procedureIncluding but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy
Device-related neurologic adverse event in 12 monthsassessed at 12 months (plus or minus 3 months) after procedureIncluding but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy
Rate of Complete aneurysm occlusion in 24 monthsassessed at 24 months (plus or minus 6 months) after procedureComplete occlusion defined as no contrast in contact with the IA neck or with the wall of the IA sac

Countries

China

Contacts

Primary ContactXinjian Yang, MD
yang-xj@163.net+86-010-59978852
Backup ContactJian Liu, MD
jianliu_ns@163.com+86-010-59978852

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026