TreatmentNCT06456697
Pipeline Embolization Device for the Treatment of Intracranial Aneurysms on the Long Term Safety and Efficacy
An observational study of Treatment, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Treatment
- How many people
- 482 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2021to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- The patient was diagnosed with intracranial aneurysms using digital subtraction angiography (DSA).
- The pipeline was successfully placed to treat intracranial aneurysms.
Who cannot join
- Patients had undergone surgery or interventional treatment before enrollment.
- During treatment, other types of stents are used in combination.
- Unable to complete the follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing
peng zhang, MD, 010-83198899, zhangpengwr@126.com
Yongjie Ma, MD, 010-83198899, mayongjiedoctor@sina.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Treatment
- Keywords
- intracranial aneurysm, Pipeline
- Medical subject headings
- Intracranial Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: 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.
Measured: assessed at 5 years (plus or minus 6 months)after procedure
Secondary outcomes (3)
Device-related neurologic adverse event in 5 years
This includes but is not limited to shortening, narrowing, and displacement of blood flow devices.
Measured: 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.
Measured: 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.
Measured: assessed at 5 years (plus or minus 6 months)after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start30 Dec 2021
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TreatmentStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 482 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Xinjiang Medical University, Beijing Tiantan Hospital, Qilu Hospital of Shandong University, Nanfang Hospital, Southern Medical University, Second Affiliated Hospital of Nanchang University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- peng zhang, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456697
- Sponsor's protocol ID
- KS2023004
- Status last verified
- May 2024
- First submitted
- 26 May 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pipeline Embolization Device for the Treatment of Intracranial Aneurysms-A Real World Study on the Long Term Safety and Efficacy(POWER)
- ClinicalTrials.gov ID
- NCT06456697
- Acronym / sponsor ID
- KS2023004
- Conditions
- Treatment
- Keywords
- intracranial aneurysm, Pipeline
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 482 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Henan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Xinjiang Medical University, Beijing Tiantan Hospital, Qilu Hospital of Shandong University, Nanfang Hospital, Southern Medical University, Second Affiliated Hospital of Nanchang University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- The patient was diagnosed with intracranial aneurysms using digital subtraction angiography (DSA).
- The pipeline was successfully placed to treat intracranial aneurysms.
Key exclusion criteria (3 listed)
- Patients had undergone surgery or interventional treatment before enrollment.
- During treatment, other types of stents are used in combination.
- Unable to complete the follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of complete aneurysm occlusion in 5 years
Time frame: assessed at 5 years (plus or minus 6 months)after procedure
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.
Rate of parent artery stenosis in 5 years
Time frame: assessed at 5 years (plus or minus 6 months)after procedure
Severe stenosis is defined as stenosis greater than 50%.
Patient prognosis in 5 years
Time frame: assessed at 5 years (plus or minus 6 months)after procedure
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.
3 secondary outcomes
Device-related neurologic adverse event in 5 years
Time frame: assessed at 5 years (plus or minus 6 months)after procedure
Occurrence of major stroke or neurovascular death in 5 years
Time frame: assessed at 5 years (plus or minus 6 months)after procedure
Brain Vascular Accident Leading to Death in 5 years
Time frame: assessed at 5 years (plus or minus 6 months)after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
Related trials for Treatment
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
peng zhang, MD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact peng zhang, MD (010-83198899, zhangpengwr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complete aneurysm occlusion in 5 years (time frame: assessed at 5 years (plus or minus 6 months)after procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.