Intracranial aneurysm treatment mainly includes craniotomy clipping and endovascular
therapy. In recent years, endovascular treatment techniques have rapidly advanced,
especially with the introduction of flow-diverting devices, which have elevated the
treatment of intracranial aneurysms to a new level. Different from previous treatment
concepts, flow-diverting devices innovate by reconstructing the blood flow in the feeding
artery. This reduces the flow velocity and volume entering the aneurysm sac, promotes
thrombosis formation inside the aneurysm sac, and induces endothelial growth at the neck
of the aneurysm. This approach aims to achieve the goal of aneurysm treatment.
The Pipeline for uncombable or failed aneurysms study (PUFS) results from North America
show that the complete occlusion rates at 180 days, 1 year, 3 years, and 5 years
follow-up for treating complex intracranial aneurysms with the Pipeline device were
73.6%, 86.8%, 93.4%, and 95.2%, respectively. The rates of significant complications were
5.6%, 1%, 3.5%, and 0%, respectively. The International Retrospective Study of the
Pipeline Embolization Device (IntrePED) is a large-scale real-world research conducted in
Europe and the United States. It has an average follow-up duration of 19.3 months (1.6
years) and shows an overall complication rate and mortality rate of 8.4%.The results of
the single-center prospective PEDESTRIAN registry study at the 5-year follow-up revealed
a complete aneurysm occlusion rate of 96.4% and an overall rate of neurological
complications, disabilities, and mortality of 5.8%. Based on the current published
research findings, there is currently a lack of a multicenter, large-scale study on the
long-term safety and effectiveness of the Pipeline flow diversion device for treating
intracranial aneurysms internationally.
In China, the pipeline flow diversion device has been in use since 2014, with thousands
of reported cases to date. Among them, a significant number of intracranial aneurysm
implant devices have been in place for over 5 years. However, there is limited research
data available on these cases in China. The most comprehensive study is the Post-Market
Multicenter Retrospective Research on Embolization Device in China (PLUS) study, with an
average follow-up time of 8.96 ± 7.5 months. The study demonstrated a complete occlusion
rate of 81.4% and a complication rate of 4.4%. However, the study primarily focuses on
the short to medium-term safety and efficacy, with a current lack of long-term related
research.
Therefore, this study aims to collect real-world data on patients with Pipeline
embolization devices implanted in a real-world setting. Through analysis, investigators
aim to gather real-world evidence on the long-term safety and effectiveness of the
Pipeline embolization device for patients with intracranial aneurysms.