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

Intracranial Aneurysm Clinical Trial

— PLUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03831672
• Other study ID #: KY2018-098-01
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2019
• Source: Beijing Neurosurgical Institute
• Contact: Xinjian Yang, MD
• Phone: +86-010-59978852
• Email: yang-xj[@]163.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Pipeline Embolization Device

Locations

Country	Name	City	State
China	Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University	Beijing	Beijing

Sponsors (13)

Lead Sponsor

Collaborator

Beijing Neurosurgical Institute

First Affiliated Hospital of Xinjiang Medical University, Group of Brain Doctors, Henan Provincial Hospital, Nanfang Hospital of Southern Medical University, Peking University International Hospital, Qilu Hospital of Shandong University, RenJi Hospital, Second Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Zhengzhou University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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