Flow DiverterNCT06943729
Clinical Safety and Efficacy of Flow-diverter in the Treatment of Intracranial Aneurysms
An observational study of Flow Diverter, run by Huashan Hospital at 1 site in China.
Trial summary
To collect the safety and effectiveness data of flow-di in the treatment of intracranial aneurysms in real-world clinical practice, verify its classification of treatment strategies for aneurysms of different locations and shapes, and optimize postoperative medication regimen, provide long-term evidence-based basis… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Flow Diverter
- How many people
- 523 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2025to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: intracranial aneurysm diagnosed by CTA, MRA or DSA (Including wide-necked aneurysms (neck width ≥4mm or Dome/neck ratio <2), saccular, fusiform aneurysms, recurrent saccular aneurysms and dissecting aneurysms, and the diameter of the parent vessel ≥ 2.0 mm and ≤ 6.0 mm
Who may be able to join
- 1)18 years ≤80 years; 2) intracranial aneurysm diagnosed by CTA, MRA or DSA (Including wide-necked aneurysms (neck width ≥4mm or Dome/neck ratio <2), saccular, fusiform aneurysms, recurrent saccular aneurysms and dissecting aneurysms, and the diameter of the parent vessel ≥ 2.0 mm and ≤ 6.0 mm; the location includes: anterior circulation C3 segment and above of internal carotid artery, distal artery of Willis circle, posterior circulation V4 segment of vertebral artery and basilar artery and its main branches; 3) Voluntary participation in this study and signing of the Informed Consent Form (ICF).
Who cannot join
- 1)AVM related aneurysm; 2) Acute ruptured aneurysm; 3) Severe stenosis or tortuosity of intracranial artery, or anatomical abnormality, which makes it difficult for the device to reach the lesion ; 4) Patients with hemorrhagic or ischemic stroke within 30 days; 5) Modified Rankin Score (mRS)>2 points before operation; 6) Patients with life expectancy less than 12 months; 7) Patients with definite history of allergy to cobalt-chromium alloy and platinum-tungsten alloy materials; Allergy to contrast media; 8) antiplatelet (PLT)<100×10^ 9 /L or/and anticoagulation contraindicated; 9) pregnant or lactating women; 10) other study participants who were assessed by the investigator as unsuitable for participation in the study.
- Intraoperative exclusion criteria: 1) acute rupture and hemorrhage of aneurysm during operation; 2) failure of FD implantation; 3) thrombosis in stent; 4) stent mal-apposition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan hospital
Shanghai, Shanghai Municipality
Gao Chao, +86 18916960799, gc_huashanneuro@sina.com
About this study
Official title: Clinical Safety and Efficacy of Flow Diverter in the Treatment of Intracranial Aneurysms
To collect the safety and effectiveness data of flow-di in the treatment of intracranial aneurysms in real-world clinical practice, verify its classification of treatment strategies for aneurysms of different locations and shapes, and optimize postoperative medication regimen, provide long-term evidence-based basis for clinical treatment of intracranial aneurysms, and build a database.
Read the detailed description
The purpose of this study is to verify the clinical safety and effectiveness of Flow Diverters (FD) in the treatment of intracranial aneurysms. In recent years, FD, as a new type of minimally invasive interventional treatment method, has been widely used in the treatment of various types of intracranial aneurysms. FD promotes the formation of thrombosis in the aneurysm by changing the hemodynamics of the aneurysm, and promotes the repair of vascular endothelium, thereby achieving tumor occlusion. In this study, 523 patients with various types of intracranial aneurysms will be recruited in 36 centers, using a multicenter, prospective, single-arm study design. The main goal of the study was to assess the complete occlusion rate of aneurysms in the 12 months after FD treatment. Secondary goals included postoperative complications (such as cerebral infarction, intracranial thrombosis), postoperative nerve function recovery, and patients' quality of life. At the same time, a large-scale domestic FD database for the treatment of intracranial aneurysms was established. The results of the study will verify the efficacy and safety of FD through clinical imaging evaluation (mainly cerebral angiography) and long-term clinical follow-up data. At the same time, the success rate of surgery and the incidence of restenosis in the stent are analyzed to comprehensively evaluate the application prospects of FD in the treatment of intracranial aneurysms. The results of this study will provide an important evidence-based basis for further promoting the clinical application of FD, optimizing the treatment plan of aneurysms, and improving the patient's prognosis.
- Conditions
- Flow Diverter
- Keywords
- Flow Diverter, Intracranial Aneurysm
- Medical subject headings
- Intracranial Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm complete occlusion rate 12 months after surgery
Measured: 12 months after surgery
Secondary outcomes (8)
Aneurysm complete occlusion rate 6 months after surgery
Measured: 6 months after surgery
Immediate success rate
Measured: Immediate
In-stent stenosis (>50% stenosis) rate 6,12 months after surgery
Measured: 6,12 months after surgery
Incidence of ipsilateral disabled stroke 3 months after surgery, 6 months after surgery, and 12 months after surgery
Measured: 3 months after surgery, 6 months after surgery, and 12 months after surgery
neurogenic death rate 6 months and 12 months after surgery
Measured: 6 months and 12 months after surgery
Target aneurysm recurrence retreatment rate 6 months and 12 months after surgery
Measured: 6 months and 12 months after surgery
Proportion of study participants with mRS score 0-2
Measured: 3 months after surgery, 6 months after surgery, and 12 months after surgery
Incidence of adverse events (AE) and severe adverse events (SAE)
Measured: 3 months after surgery, 6 months after surgery, and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start27 Apr 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flow DiverterStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe 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
- Prospective
- Enrolment
- 523 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xinqiao Hospital of Chongqing, Ningbo No.2 Hospital, Eighth Affiliated Hospital, Sun Yat-sen University, Second Affiliated Hospital of Nanchang University, Jiangxi Provincial People's Hopital, Zhengzhou Central Hospital, Xuchang Central Hospital, Second People's Hospital of Hunan, People's Hospital Of Ningxiang City, The First People's Hospital of Changde City, HUANG GANG Central Hospital, Xianning Central Hospital, Jingzhou Central Hospital, Yichang Central People's Hospital, The First People's Hospital of Changzhou, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Northern Jiangsu People's Hospital, Suzhou Municipal Hospital, Jiangsu Taizhou People's Hospital, Huadong Hospital, RenJi Hospital, Shanghai Zhongshan Hospital, Shanghai Fourth People's Hospital, Shanghai Donglei Brain Hospital, Shanghai Pudong New Area People's Hospital, Shanghai East Hospital of Tongji University, First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Xi'an Jiaotong University, Tangshan Gongren Hospital, The Second Hospital of Hebei Medical University, Hebei General Hospital, Xingtai People's Hospital, Peking University First Hospital, THE AFFILIATED SUZHOU HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL, The Second Affiliated Hospital of Kunming Medical University
- Responsible party
- Principal investigator, Yuxiang Gu, Huashan Hospital
- Investigators
- Gu Yuxiang, PhD, Study chair, department of Neurosurgery, Huashan Hospital,Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943729
- Sponsor's protocol ID
- KY2025-698
- Status last verified
- Aug 2025
- First submitted
- 14 Apr 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety and Efficacy of Flow Diverter in the Treatment of Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT06943729
- Acronym / sponsor ID
- KY2025-698
- Conditions
- Flow Diverter
- Keywords
- Flow Diverter, Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 523 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Xinqiao Hospital of Chongqing, Ningbo No.2 Hospital, Eighth Affiliated Hospital, Sun Yat-sen University, Second Affiliated Hospital of Nanchang University, Jiangxi Provincial People's Hopital, Zhengzhou Central Hospital, Xuchang Central Hospital, Second People's Hospital of Hunan, People's Hospital Of Ningxiang City, The First People's Hospital of Changde City, HUANG GANG Central Hospital, Xianning Central Hospital, Jingzhou Central Hospital, Yichang Central People's Hospital, The First People's Hospital of Changzhou, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Northern Jiangsu People's Hospital, Suzhou Municipal Hospital, Jiangsu Taizhou People's Hospital, Huadong Hospital, RenJi Hospital, Shanghai Zhongshan Hospital, Shanghai Fourth People's Hospital, Shanghai Donglei Brain Hospital, Shanghai Pudong New Area People's Hospital, Shanghai East Hospital of Tongji University, First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Xi'an Jiaotong University, Tangshan Gongren Hospital, The Second Hospital of Hebei Medical University, Hebei General Hospital, Xingtai People's Hospital, Peking University First Hospital, THE AFFILIATED SUZHOU HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL, The Second Affiliated Hospital of Kunming Medical University
- Study start
- 27 Apr 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 24 Apr 2025 (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.
To collect the safety and effectiveness data of flow-di in the treatment of intracranial aneurysms in real-world clinical practice, verify its classification of treatment strategies for aneurysms of different locations and shapes, and optimize postoperative medication regimen, provide long-term evidence-based basis for clinical treatment of intracranial aneurysms, and build a database.
Detailed description
The purpose of this study is to verify the clinical safety and effectiveness of Flow Diverters (FD) in the treatment of intracranial aneurysms. In recent years, FD, as a new type of minimally invasive interventional treatment method, has been widely used in the treatment of various types of intracranial aneurysms. FD promotes the formation of thrombosis in the aneurysm by changing the hemodynamics of the aneurysm, and promotes the repair of vascular endothelium, thereby achieving tumor occlusion. In this study, 523 patients with various types of intracranial aneurysms will be recruited in 36 centers, using a multicenter, prospective, single-arm study design. The main goal of the study was to assess the complete occlusion rate of aneurysms in the 12 months after FD treatment. Secondary goals included postoperative complications (such as cerebral infarction, intracranial thrombosis), postoperative nerve function recovery, and patients' quality of life. At the same time, a large-scale domestic FD database for the treatment of intracranial aneurysms was established. The results of the study will verify the efficacy and safety of FD through clinical imaging evaluation (mainly cerebral angiography) and long-term clinical follow-up data. At the same time, the success rate of surgery and the incidence of restenosis in the stent are analyzed to comprehensively evaluate the application prospects of FD in the treatment of intracranial aneurysms. The results of this study will provide an important evidence-based basis for further promoting the clinical application of FD, optimizing the treatment plan of aneurysms, and improving the patient's prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- intracranial aneurysm diagnosed by CTA, MRA or DSA (Including wide-necked aneurysms (neck width ≥4mm or Dome/neck ratio <2), saccular, fusiform aneurysms, recurrent saccular aneurysms and dissecting aneurysms, and the diameter of the parent vessel ≥ 2.0 mm and ≤ 6.0 mm
Key inclusion criteria (1 listed)
- 1)18 years ≤80 years; 2) intracranial aneurysm diagnosed by CTA, MRA or DSA (Including wide-necked aneurysms (neck width ≥4mm or Dome/neck ratio <2), saccular, fusiform aneurysms, recurrent saccular aneurysms and dissecting aneurysms, and the diameter of the parent vessel ≥ 2.0 mm and ≤ 6.0 mm; the location includes: anterior circulation C3 segment and above of internal carotid artery, distal artery of Willis circle, posterior circulation V4 segment of vertebral artery and basilar artery and its main branches; 3) Voluntary participation in this study and signing of the Informed Consent Form (ICF).
Key exclusion criteria (2 listed)
- 1)AVM related aneurysm; 2) Acute ruptured aneurysm; 3) Severe stenosis or tortuosity of intracranial artery, or anatomical abnormality, which makes it difficult for the device to reach the lesion ; 4) Patients with hemorrhagic or ischemic stroke within 30 days; 5) Modified Rankin Score (mRS)>2 points before operation; 6) Patients with life expectancy less than 12 months; 7) Patients with definite history of allergy to cobalt-chromium alloy and platinum-tungsten alloy materials; Allergy to contrast media; 8) antiplatelet (PLT)<100×10^ 9 /L or/and anticoagulation contraindicated; 9) pregnant or lactating women; 10) other study participants who were assessed by the investigator as unsuitable for participation in the study.
- Intraoperative exclusion criteria: 1) acute rupture and hemorrhage of aneurysm during operation; 2) failure of FD implantation; 3) thrombosis in stent; 4) stent mal-apposition.
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
Aneurysm complete occlusion rate 12 months after surgery
Time frame: 12 months after surgery
8 secondary outcomes
Aneurysm complete occlusion rate 6 months after surgery
Time frame: 6 months after surgery
Immediate success rate
Time frame: Immediate
In-stent stenosis (>50% stenosis) rate 6,12 months after surgery
Time frame: 6,12 months after surgery
Incidence of ipsilateral disabled stroke 3 months after surgery, 6 months after surgery, and 12 months after surgery
Time frame: 3 months after surgery, 6 months after surgery, and 12 months after surgery
neurogenic death rate 6 months and 12 months after surgery
Time frame: 6 months and 12 months after surgery
Target aneurysm recurrence retreatment rate 6 months and 12 months after surgery
Time frame: 6 months and 12 months after surgery
Proportion of study participants with mRS score 0-2
Time frame: 3 months after surgery, 6 months after surgery, and 12 months after surgery
Incidence of adverse events (AE) and severe adverse events (SAE)
Time frame: 3 months after surgery, 6 months after surgery, and 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Gu Yuxiang, PhD study chair
department of Neurosurgery, Huashan Hospital,Fudan University
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 Flow Diverter, run by Huashan Hospital 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gao Chao, PhD (18916960799, gc_huashanneuro@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aneurysm complete occlusion rate 12 months after surgery (time frame: 12 months after surgery). 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 29 Aug 2025.