Clinical trial NCT06456697: Pipeline Embolization Device for the Treatment of Intracranial Aneurysms on the Long Term Safety and Efficacy
Official title: Pipeline Embolization Device for the Treatment of Intracranial Aneurysms-A Real World Study on the Long Term Safety and Efficacy(POWER)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Treatment
Keywords: intracranial aneurysm
Pipeline
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Henan Provincial People's Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: First Affiliated Hospital of Xinjiang Medical University
name: Beijing Tiantan Hospital
name: Qilu Hospital of Shandong University
name: Nanfang Hospital, Southern Medical University
name: Second Affiliated Hospital of Nanchang University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Wuhan Union Hospital, China
First posted: 2024-06-13
Enrollment: 482
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was conducted in 10 centers in the country. According to previous literature, the reported occlusion rate ranges from 81.4% to 95.2% \[8-12\], and the occlusion rate increases with longer follow-up time. In this study, the occlusion rate was calculated at 90%, with a permissible error control of 3%. With α=0.05, the sample size was calculated to be 385. Anticipating a dropout rate of 20%, the sample size needed is 482 cases.

Brief summary: Since its launch in China in 2014, Pipeline Embolization Device (PED) has been widely used in the treatment of intracranial aneurysms. It is necessary to collect data on the long-term safety and efficacy of the Pipeline Embolization Device (PED) in the treatment of intracranial aneurysms, analyze its long-term effectiveness, and provide guidance for clinical practice.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. The patient was diagnosed with intracranial aneurysms using digital subtraction angiography (DSA).
2. The pipeline was successfully placed to treat intracranial aneurysms.

Exclusion Criteria:

1. Patients had undergone surgery or interventional treatment before enrollment.
2. During treatment, other types of stents are used in combination.
3. Unable to complete the follow-up.

Primary outcomes:
measure: Rate of complete aneurysm occlusion in 5 years
timeFrame: assessed at 5 years (plus or minus 6 months)after procedure
measure: Rate of parent artery stenosis in 5 years
timeFrame: assessed at 5 years (plus or minus 6 months)after procedure
measure: Patient prognosis in 5 years
timeFrame: assessed at 5 years (plus or minus 6 months)after procedure
Secondary outcomes:
measure: Device-related neurologic adverse event in 5 years
timeFrame: assessed at 5 years (plus or minus 6 months)after procedure
measure: Occurrence of major stroke or neurovascular death in 5 years
timeFrame: assessed at 5 years (plus or minus 6 months)after procedure
measure: Brain Vascular Accident Leading to Death in 5 years
timeFrame: assessed at 5 years (plus or minus 6 months)after procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: peng zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: