Intracranial Non-saccular AneurysmsSAEFDNCT07205302
Safety and Efficacy of the Flow Diverter in the Treatment of Intracranial Non-saccular Aneurysm
An observational study of Intracranial Non-saccular Aneurysms, run by RenJi Hospital.
Trial summary
Using data obtained from the treatment of intracranial non-saccular aneurysms with flow diverter, evaluate the effecy and safety of blood flow diverter for the endovascular treatment of intracranial non-saccular aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Non-saccular Aneurysms
- What is being tested?
- flow diverter
- Type of treatment
- Medical device
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2025to 31 Dec 2028
- How long will I take part?
- 1 Year
- 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
- Adult, Older adult
Study population: patients with intracranial Non-saccular aneurysm
Who may be able to join
- Age 18 to 80 years, any gender
- Diagnosed as a non-saccular aneurysm in the patient's intracranial region
- Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form
Who cannot join
- Aneurysm rupture within 30 days before enrollment;
- Diagnosis of multiple aneurysms and requiring reoperation within 12 months
- Conditions that are not appropriate for stent delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.);
- Heart, lung, liver and renal failure or other severe diseases (intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery, etc.);
- Major surgery within 30 days before enrollment，or planned to undergo surgery within 360 days after enrollment;
- Known allergies or contraindications to anesthetics, anticoagulants, and antiplatelet drugs;
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- Known allergy to nickel-titanium alloy metal materials;
- Life expectancy <12 months;
- Pregnant or breastfeeding women;
- Subject has participated in other clinical trials within 1 month before signing informed consent;
- Other conditions judged by the investigators as unsuitable for enrollment.
About this study
Using data obtained from the treatment of intracranial non-saccular aneurysms with flow diverter, evaluate the effecy and safety of blood flow diverter for the endovascular treatment of intracranial non-saccular aneurysms.
- Conditions
- Intracranial Non-saccular Aneurysms
- Being tested
- flow diverter
- Keywords
- intracranial non-saccular aneurysms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flow diverterDevice
the treatment of intracranial non-saccular aneurysms with flow diverter
| Study group | Role | What they receive |
|---|---|---|
| FD | treatment of intracranial non-saccular aneurysms with flow diverter Receives: Device: flow diverter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete occlusion rate of aneurysm 12 months after surgery
Complete occlusion is defined as no significant blood flow ,and achieves Raymond-Roy class I , which is diagnosed by cerebrovascular DSA at 6 months post-procedure.
Measured: 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 posted3 Oct 2025
- Study start8 Oct 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Non-saccular AneurysmsStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 168 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205302
- Sponsor's protocol ID
- RJSW202504
- Acronym
- SAEFD
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Flow Diverter in the Treatment of Intracranial Non-saccular Aneurysm
- ClinicalTrials.gov ID
- NCT07205302
- Acronym / sponsor ID
- SAEFD / RJSW202504
- Conditions
- Intracranial Non-saccular Aneurysms
- Keywords
- intracranial non-saccular aneurysms
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 8 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Oct 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.
Using data obtained from the treatment of intracranial non-saccular aneurysms with flow diverter, evaluate the effecy and safety of blood flow diverter for the endovascular treatment of intracranial non-saccular aneurysms.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FD | – | Device: flow divertertreatment of intracranial non-saccular aneurysms with flow diverter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with intracranial Non-saccular aneurysm
Key inclusion criteria (3 listed)
- Age 18 to 80 years, any gender
- Diagnosed as a non-saccular aneurysm in the patient's intracranial region
- Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form
Key exclusion criteria (11 listed)
- Aneurysm rupture within 30 days before enrollment;
- Diagnosis of multiple aneurysms and requiring reoperation within 12 months
- Conditions that are not appropriate for stent delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.);
- Heart, lung, liver and renal failure or other severe diseases (intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery, etc.);
- Major surgery within 30 days before enrollment，or planned to undergo surgery within 360 days after enrollment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flow diverterthe treatment of intracranial non-saccular aneurysms with flow diverter | Device | FD |
Primary outcome
Complete occlusion rate of aneurysm 12 months after surgery
Time frame: 12 months after surgery
Complete occlusion is defined as no significant blood flow ,and achieves Raymond-Roy class I , which is diagnosed by cerebrovascular DSA at 6 months post-procedure.
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 3 Oct 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Non-saccular Aneurysms, run by RenJi Hospital.
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 3 inclusion and 11 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: opening soon, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete occlusion rate of aneurysm 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 3 Oct 2025.