Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456697
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-26
Brief Title:
Pipeline Embolization Device for the Treatment of Intracranial Aneurysms on the Long Term Safety and Efficacy
Sponsor:
Xuanwu Hospital Beijing
Organization:
Xuanwu Hospital Beijing
Study Overview
Official Title:
Pipeline Embolization Device for the Treatment of Intracranial Aneurysms-A Real World Study on the Long Term Safety and EfficacyPOWER
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 736 868 934 and 952 respectively The rates of significant complications were 56 1 35 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 193 months 16 years and shows an overall complication rate and mortality rate of 84The results of the single-center prospective PEDESTRIAN registry study at the 5-year follow-up revealed a complete aneurysm occlusion rate of 964 and an overall rate of neurological complications disabilities and mortality of 58 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 896 75 months The study demonstrated a complete occlusion rate of 814 and a complication rate of 44 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
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 736 868 934 and 952 respectively The rates of significant complications were 56 1 35 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 193 months 16 years and shows an overall complication rate and mortality rate of 84The results of the single-center prospective PEDESTRIAN registry study at the 5-year follow-up revealed a complete aneurysm occlusion rate of 964 and an overall rate of neurological complications disabilities and mortality of 58 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 896 75 months The study demonstrated a complete occlusion rate of 814 and a complication rate of 44 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None