Intracranial AneurysmPLUSNCT03831672
Post Market Multi-Center Retrospective Research on Embolization of Intracranial Aneurysms With Pipeline Embolization Device in China
An observational study of Intracranial Aneurysm and Pipeline Embolization Device, run by Beijing Neurosurgical Institute at 1 site in China.
Trial summary
Pipeline TM embolization device launched to China in 2014, and has been widely used to treat large width IA. Therefore, it is necessary to collect and analysis the clinical data to evaluate effectiveness and safety of its usage in Chinese population, and this may guide the clinical practice and meet the clinical needs… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracranial Aneurysm, Pipeline Embolization Device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 30 Jun 2019
- 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: The trial is intended to conduct in 13 centers in China. The sample size of this study was calculated based on the embolization rate of aneurysm. According to the existing overseas research data, we assume that the one-year embolization rate of Pipeline treatment for aneurysms is about 70%. Under the condition that the allowable error is 10% and the inspection level is 0.05, 162 cases are needed in this study. Considering the heterogeneity of different centers, the further expanded sample size is 200 cases.
Who may be able to join
- Patients accepting to participate the study
- Patients treated with Pipeline
Who cannot join
- Patients treated by parent vessel occlusion
- Patients treated by other stent
- Patients lacking 3-dimensional aneurysm images or the images not satisfied the simulation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100050
Xinjian Yang, MD, +86-010-59978852, yangxinjian@bjttyy.org
Jian Liu, MD, +86-010-59978852, jianliu_ns@163.com
About this study
Official title: Post Market Multi-Center Retrospective Research on Embolization of Intracranial Aneurysms With Pipeline Embolization Device in China (PLUS)
Pipeline TM embolization device launched to China in 2014, and has been widely used to treat large width IA. Therefore, it is necessary to collect and analysis the clinical data to evaluate effectiveness and safety of its usage in Chinese population, and this may guide the clinical practice and meet the clinical needs better.
Read the detailed description
Recent years, the rapid development of endovascular treatment, especially the introduction of blood flow diverter device, has led to a new step in the treatment of intracranial aneurysms. It is different from usual treatment concept, blood flow diverter device's innovation is guiding to its parent artery reconstruction by cutting into the blood flow velocity and flow rate to the IA, and, promote the forming of aneurysm cavity thrombosis and the Neointima growth of IA's neck, so that to achieve aneurysm treatment.
A number of multi-center clinical studies on Pipeline embolization devices (PED, Ev3 Company/Medtronic, USA) have been conducted in North America and Europe recently. Becske etc reported the result of one multi-center prospective clinical trial of North America (PUFS), the PED treats the complicated intracranial internal carotid artery aneurysm. At the time of 180 days, 1 year, 3 years follow-up, the complete occlusion rate were 73.6%, 86.8% and 93.4% respectively. O 'kelly etc. the study showed that the rate of subtotal occlusion over 1 year follow-up of PED treatment for complex intracranial aneurysms was 90%. Many studies have confirmed the effectiveness of PED in the treatment of complex intracranial aneurysms.
The main motivation to innovate the blood flow diverter device is to use it to treat some large or giant aneurysms, fusiform aneurysm which can't be treated well by ordinary interventional embolization methods. So, in the initial stage of the application, its indications are mainly focus on the large or giant aneurysms located in the internal carotid artery before the origin of the posterior communicating artery. In recent years, the blood flow diverter devices were already used to treat many kinds of IA in almost all parts of the brain, different sizes and with pathological changes, such as dissecting aneurysms and vesicular aneurysms.
Although there was already much clinical research evidence which proved the efficacy and safety of PipelineTM 's treatment to the aneurysm as the embolization device, but these data are all from the foreign population, there is still no published clinical evidence of large sample size clinical study of Chinese population. Pipeline has been widely used to treat large width IA. Therefore, it's meaningful to evaluate effectiveness and safety in Chinese population, and this may guide the clinical practice and meet the clinical needs better.
- Keywords
- intracranial aneurysm, outcome, occlusion, Pipeline embolization device, endovascular treatment, flow diversion
- Medical subject headings
- Intracranial Aneurysm, Bites and Stings
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete aneurysm occlusion in 12 months
Complete occlusion defined as no contrast in contact with the IA neck or with the wall of the IA sac
Measured: assessed at 12 months (plus or minus 3 months) after procedure
Occurrence of ipsilateral major stroke or neurovascular death in 12 months
Including but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy
Measured: assessed at 12 months (plus or minus 3 months) after procedure
Secondary outcomes (5)
Rate of Complete aneurysm occlusion in 6 months
Complete occlusion defined as no contrast in contact with the IA neck or with the wall of the IA sac
Measured: assessed at 6 months (plus or minus 3 months) after procedure
Rate of Complete aneurysm occlusion in 24 months
Complete occlusion defined as no contrast in contact with the IA neck or with the wall of the IA sac
Measured: assessed at 24 months (plus or minus 6 months) after procedure
Occurrence of ipsilateral major stroke or neurovascular death in 1 month
Including but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy
Measured: assessed at 1 month (plus or minus 0.5 month) after procedure
Device-related neurologic adverse event in 12 months
Including but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy
Measured: assessed at 12 months (plus or minus 3 months) after procedure
Occurrence of ipsilateral major stroke or neurovascular death in 24 months
Including but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy
Measured: assessed at 24 months (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 posted6 Feb 2019
- Study start1 Nov 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Neurosurgical Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Henan Provincial People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Group of Brain Doctors, Peking University International Hospital, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Xinjiang Medical University, Qilu Hospital of Shandong University, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital of Nanchang University, RenJi Hospital, Second Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Xinjian Yang, MD, Beijing Neurosurgical Institute
- Investigators
- Xinjian Yang, MD, Principal investigator, Beijing Neurosurgical Institute and Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831672
- Sponsor's protocol ID
- KY2018-098-01
- Acronym
- PLUS
- Status last verified
- Feb 2019
- First submitted
- 28 Jan 2019
- Last updated
- 11 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Y, Zhang F, Turhon M, Huang J, Li M, Peng Q, Zheng Z, Liu J, Zhang Y, Liu J, Zhang H, Li T, Song D, Zhao Y, Aisha M, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Guan S. Treatment of Intracranial Vertebral Artery Dissecting Aneurysms Using Pipeline Embolization Devices : A Multicenter Cohort Study. Clin Neuroradiol. 2023 Dec;33(4):1105-1114. doi: 10.1007/s00062-023-01318-7. Epub 2023 Jun 28.
PubMed 37380901Zhao Y, Lu J, Zhang H, Li T, Song D, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J, Zhao Y. Pipeline Embolization Device for intracranial aneurysms presenting with mass effect: a large Chinese cohort. Stroke Vasc Neurol. 2024 Feb 27;9(1):50-58. doi: 10.1136/svn-2022-002213.
PubMed 37295810Lu J, Zhao Y, Zhang H, Li T, Song D, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J, Zhao Y. Learning curve in pipeline embolization device: results from the pipeline embolization device in China post-market multicentre registry study. Int J Surg. 2023 Aug 1;109(8):2159-2167. doi: 10.1097/JS9.0000000000000467.
PubMed 37158157Zhang H, Li L, Zhang H, Liu J, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Luo B, Shao Q, Chang K, Zhang Q, He Y, Zhang P, Yang X, Li TX. Small and Medium-Sized Aneurysm Outcomes Following Intracranial Aneurysm Treatment Using the Pipeline Embolization Device: A Subgroup Analysis of the PLUS Registry. Front Neurol. 2022 May 31;13:881353. doi: 10.3389/fneur.2022.881353. eCollection 2022.
PubMed 35711259Xu C, Wu P, Han J, Sun B, Wang C, Xu S, Luo B, Yang X, Mu Q, Shi H. Safety Evaluation and Flow Modification in the Anterior Cerebral Artery after Pipeline Embolization Device Deployment across the Internal Carotid Artery Terminus. Biomed Res Int. 2021 Aug 21;2021:6657595. doi: 10.1155/2021/6657595. eCollection 2021.
PubMed 34471639Kang H, Luo B, Liu J, Wang A, Zhang H, Li T, Song D, Zhao Y, Guan S, Wang Y, Feng W, Wang Y, Shi H, Liu J, Yang X. A novel score for evaluating cerebral aneurysms treated with flow diversion: 4F-flow diversion predictive score. Ther Adv Neurol Disord. 2021 Aug 19;14:17562864211039336. doi: 10.1177/17562864211039336. eCollection 2021.
PubMed 34434256Kang H, Zhou Y, Luo B, Lv N, Zhang H, Li T, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J. Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis. Neurotherapeutics. 2021 Apr;18(2):1198-1206. doi: 10.1007/s13311-020-00990-8. Epub 2021 Jan 14.
PubMed 33447904Luo B, Kang H, Zhang H, Li T, Liu J, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X. Pipeline Embolization device for intracranial aneurysms in a large Chinese cohort: factors related to aneurysm occlusion. Ther Adv Neurol Disord. 2020 Nov 2;13:1756286420967828. doi: 10.1177/1756286420967828. eCollection 2020.
PubMed 33224273
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Multi-Center Retrospective Research on Embolization of Intracranial Aneurysms With Pipeline Embolization Device in China (PLUS)
- ClinicalTrials.gov ID
- NCT03831672
- Acronym / sponsor ID
- PLUS / KY2018-098-01
- Keywords
- intracranial aneurysm, outcome, occlusion, Pipeline embolization device, endovascular treatment, flow diversion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Neurosurgical InstituteUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Henan Provincial People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Group of Brain Doctors, Peking University International Hospital, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Xinjiang Medical University, Qilu Hospital of Shandong University, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital of Nanchang University, RenJi Hospital, Second Affiliated Hospital of Nanchang University
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 6 Feb 2019 (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.
Pipeline TM embolization device launched to China in 2014, and has been widely used to treat large width IA. Therefore, it is necessary to collect and analysis the clinical data to evaluate effectiveness and safety of its usage in Chinese population, and this may guide the clinical practice and meet the clinical needs better.
Detailed description
Recent years, the rapid development of endovascular treatment, especially the introduction of blood flow diverter device, has led to a new step in the treatment of intracranial aneurysms. It is different from usual treatment concept, blood flow diverter device's innovation is guiding to its parent artery reconstruction by cutting into the blood flow velocity and flow rate to the IA, and, promote the forming of aneurysm cavity thrombosis and the Neointima growth of IA's neck, so that to achieve aneurysm treatment.
A number of multi-center clinical studies on Pipeline embolization devices (PED, Ev3 Company/Medtronic, USA) have been conducted in North America and Europe recently. Becske etc reported the result of one multi-center prospective clinical trial of North America (PUFS), the PED treats the complicated intracranial internal carotid artery aneurysm. At the time of 180 days, 1 year, 3 years follow-up, the complete occlusion rate were 73.6%, 86.8% and 93.4% respectively. O 'kelly etc. the study showed that the rate of subtotal occlusion over 1 year follow-up of PED treatment for complex intracranial aneurysms was 90%. Many studies have confirmed the effectiveness of PED in the treatment of complex intracranial aneurysms.
The main motivation to innovate the blood flow diverter device is to use it to treat some large or giant aneurysms, fusiform aneurysm which can't be treated well by ordinary interventional embolization methods. So, in the initial stage of the application, its indications are mainly focus on the large or giant aneurysms located in the internal carotid artery before the origin of the posterior communicating artery. In recent years, the blood flow diverter devices were already used to treat many kinds of IA in almost all parts of the brain, different sizes and with pathological changes, such as dissecting aneurysms and vesicular aneurysms.
Although there was already much clinical research evidence which proved the efficacy and safety of PipelineTM 's treatment to the aneurysm as the embolization device, but these data are all from the foreign population, there is still no published clinical evidence of large sample size clinical study of Chinese population. Pipeline has been widely used to treat large width IA. Therefore, it's meaningful to evaluate effectiveness and safety in Chinese population, and this may guide the clinical practice and meet the clinical needs better.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The trial is intended to conduct in 13 centers in China. The sample size of this study was calculated based on the embolization rate of aneurysm. According to the existing overseas research data, we assume that the one-year embolization rate of Pipeline treatment for aneurysms is about 70%. Under the condition that the allowable error is 10% and the inspection level is 0.05, 162 cases are needed in this study. Considering the heterogeneity of different centers, the further expanded sample size is 200 cases.
Key inclusion criteria (2 listed)
- Patients accepting to participate the study
- Patients treated with Pipeline
Key exclusion criteria (3 listed)
- Patients treated by parent vessel occlusion
- Patients treated by other stent
- Patients lacking 3-dimensional aneurysm images or the images not satisfied the simulation
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 12 months
Time frame: assessed at 12 months (plus or minus 3 months) after procedure
Complete occlusion defined as no contrast in contact with the IA neck or with the wall of the IA sac
Occurrence of ipsilateral major stroke or neurovascular death in 12 months
Time frame: assessed at 12 months (plus or minus 3 months) after procedure
Including but not limited: Spontaneous rupture of the target aneurysm, Ipsilateral intracranial hemorrhage, Ischemic stroke, Symptomatic parent artery stenosis, Permanent cranial neuropathy
5 secondary outcomes
Rate of Complete aneurysm occlusion in 6 months
Time frame: assessed at 6 months (plus or minus 3 months) after procedure
Rate of Complete aneurysm occlusion in 24 months
Time frame: assessed at 24 months (plus or minus 6 months) after procedure
Occurrence of ipsilateral major stroke or neurovascular death in 1 month
Time frame: assessed at 1 month (plus or minus 0.5 month) after procedure
Device-related neurologic adverse event in 12 months
Time frame: assessed at 12 months (plus or minus 3 months) after procedure
Occurrence of ipsilateral major stroke or neurovascular death in 24 months
Time frame: assessed at 24 months (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 11 Feb 2019.
- Derived from this study: PubMed 37380901Zhang Y, Zhang F, Turhon M, Huang J, Li M, Peng Q, Zheng Z, Liu J, Zhang Y, Liu J, Zhang H, Li T, Song D, Zhao Y, Aisha M, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Guan S. Treatment of Intracranial Vertebral Artery Dissecting Aneurysms Using Pipeline Embolization Devices : A Multicenter Cohort Study. Clin Neuroradiol. 2023 Dec;33(4):1105-1114. doi: 10.1007/s00062-023-01318-7. Epub 2023 Jun 28.
- Derived from this study: PubMed 37295810Zhao Y, Lu J, Zhang H, Li T, Song D, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J, Zhao Y. Pipeline Embolization Device for intracranial aneurysms presenting with mass effect: a large Chinese cohort. Stroke Vasc Neurol. 2024 Feb 27;9(1):50-58. doi: 10.1136/svn-2022-002213.
- Derived from this study: PubMed 37158157Lu J, Zhao Y, Zhang H, Li T, Song D, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J, Zhao Y. Learning curve in pipeline embolization device: results from the pipeline embolization device in China post-market multicentre registry study. Int J Surg. 2023 Aug 1;109(8):2159-2167. doi: 10.1097/JS9.0000000000000467.
- Derived from this study: PubMed 35711259Zhang H, Li L, Zhang H, Liu J, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Luo B, Shao Q, Chang K, Zhang Q, He Y, Zhang P, Yang X, Li TX. Small and Medium-Sized Aneurysm Outcomes Following Intracranial Aneurysm Treatment Using the Pipeline Embolization Device: A Subgroup Analysis of the PLUS Registry. Front Neurol. 2022 May 31;13:881353. doi: 10.3389/fneur.2022.881353. eCollection 2022.
- Derived from this study: PubMed 34471639Xu C, Wu P, Han J, Sun B, Wang C, Xu S, Luo B, Yang X, Mu Q, Shi H. Safety Evaluation and Flow Modification in the Anterior Cerebral Artery after Pipeline Embolization Device Deployment across the Internal Carotid Artery Terminus. Biomed Res Int. 2021 Aug 21;2021:6657595. doi: 10.1155/2021/6657595. eCollection 2021.
- Derived from this study: PubMed 34434256Kang H, Luo B, Liu J, Wang A, Zhang H, Li T, Song D, Zhao Y, Guan S, Wang Y, Feng W, Wang Y, Shi H, Liu J, Yang X. A novel score for evaluating cerebral aneurysms treated with flow diversion: 4F-flow diversion predictive score. Ther Adv Neurol Disord. 2021 Aug 19;14:17562864211039336. doi: 10.1177/17562864211039336. eCollection 2021.
- Derived from this study: PubMed 33447904Kang H, Zhou Y, Luo B, Lv N, Zhang H, Li T, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J. Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis. Neurotherapeutics. 2021 Apr;18(2):1198-1206. doi: 10.1007/s13311-020-00990-8. Epub 2021 Jan 14.
- Derived from this study: PubMed 33224273Luo B, Kang H, Zhang H, Li T, Liu J, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X. Pipeline Embolization device for intracranial aneurysms in a large Chinese cohort: factors related to aneurysm occlusion. Ther Adv Neurol Disord. 2020 Nov 2;13:1756286420967828. doi: 10.1177/1756286420967828. eCollection 2020.
Related trials for Intracranial Aneurysm
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
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.
Xinjian Yang, MD principal investigator
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
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 Intracranial Aneurysm and Pipeline Embolization Device, run by Beijing Neurosurgical Institute 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 11 Feb 2019. 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 Xinjian Yang, MD (+86-010-59978852, yang-xj@163.net), 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 12 months (time frame: assessed at 12 months (plus or minus 3 months) after procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03831672, which also lists 8 linked publications.
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 11 Feb 2019.