Pipeline Embolization Device for the Treatment of Intracranial Aneurysms on the Long Term Safety and Efficacy

Pipeline Embolization Device for the Treatment of Intracranial Aneurysms-A Real World Study on the Long Term Safety and Efficacy(POWER)

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.

Study Overview

• Status: Recruiting
• Conditions: Treatment

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.

• Study Type: Observational
• Enrollment (Estimated): 482

Contacts and Locations

• Study Contact: Name: Peng Zhang, MD; Phone Number: 010-83198899; Email: zhangpengwr@126.com
• Study Contact Backup: Name: Yongjie Ma, MD; Phone Number: 010-83198899; Email: mayongjiedoctor@sina.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Xuanwu Hospital, Capital Medical University
    • Contact: Peng Zhang, MD; Phone Number: 010-83198899; Email: zhangpengwr@126.com
    • Contact: Yongjie Ma, MD; Phone Number: 010-83198899; Email: mayongjiedoctor@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of complete aneurysm occlusion in 5 years	The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Success aneurysm occlusion in which class 1 or 2 is achieved on the Raymond-Roy occlusion classification Scale at the 5 year follow-up angiographic assessments will be evaluated.	assessed at 5 years (plus or minus 6 months)after procedure
Rate of parent artery stenosis in 5 years	Severe stenosis is defined as stenosis greater than 50%.	assessed at 5 years (plus or minus 6 months)after procedure
Patient prognosis in 5 years	Assessing patient prognosis using Modified Rankin Scale (mRS) scores. mRS is scored on a scale of 0 to 6, with a higher score indicating a more severe condition.	assessed at 5 years (plus or minus 6 months)after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related neurologic adverse event in 5 years	This includes but is not limited to shortening, narrowing, and displacement of blood flow devices.	assessed at 5 years (plus or minus 6 months)after procedure
Occurrence of major stroke or neurovascular death in 5 years	This includes but is not limited to ruptured aneurysm, intracerebral hemorrhage on the same side, ischemic stroke, symptomatic stenosis of the feeding artery, and other permanent neurological impairments.	assessed at 5 years (plus or minus 6 months)after procedure
Brain Vascular Accident Leading to Death in 5 years	Due to other vascular accidents, death occurred.	assessed at 5 years (plus or minus 6 months)after procedure

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Beijing Tiantan Hospital; Qilu Hospital of Shandong University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The First Affiliated Hospital of Zhengzhou University; Henan Provincial People's Hospital; Wuhan Union Hospital, China; First Affiliated Hospital of Xinjiang Medical University; Second Affiliated Hospital of Nanchang University; Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Peng Zhang, MD, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2021
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 26, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: intracranial aneurysm; Pipeline
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: KS2023004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No