Cerebral Aneurysm UnrupturedNCT07190781
Development Platform Construction and Application Promotion of Drug-Eluting Stents for Intracranial Aneurysm Interventional Therapy
An observational study of Cerebral Aneurysm Unruptured, run by Xinjian Yang at 1 site in China.
Trial summary
This study is a post-marketing clinical study of the Lattice Flow-Diverting Dense-Mesh Stent. It plans to enroll 280 patients, who will be treated for unruptured intracranial aneurysms using the Lattice Flow-Diverting Dense-Mesh Stent. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Aneurysm Unruptured
- What is being tested?
- Flow-Diverting Dense-Mesh Stent
- Type of treatment
- Medical device
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2022to Dec 2026
- 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: Patients diagnosed with unruptured intracranial aneurysms via CTA , MRA , or DSA
Inclusion Criteria:Inclusion Criteria Aged 18 years or older; Patients diagnosed with unruptured intracranial aneurysms via CTA (Computed Tomographic Angiography), MRA (Magnetic Resonance Angiography), or DSA (Digital Subtraction Angiography); Patients treated with the Lattice Flow-Diverting Dense-Mesh Stent; Patients with 12-month follow-up records after treatment with the Lattice Flow-Diverting Dense-Mesh Stent; Patients whose aneurysms and parent arteries meet the indications for the Lattice Flow-Diverting Dense-Mesh Stent.
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Exclusion Criteria:Patients with severe respiratory, circulatory, hepatic, renal diseases, or coagulation disorders; Patients whose target aneurysms are pseudoaneurysms, or aneurysms associated with arteriovenous malformations (AVMs) or Moyamoya disease; Patients with intracranial space-occupying lesions (such as intracranial tumors, abscesses, etc.), or those undergoing radiotherapy to the head; Patients currently participating in clinical trials of other drugs or medical devices; Patients with incomplete follow-up information 12 months after treatment with the Lattice Flow-Diverting Dense-Mesh Stent; Patients who express explicit disagreement (verbally or in writing) with participating in this study; Patients with parent artery stenosis greater than 50% that requires balloon angioplasty.
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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
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
This study is a post-marketing clinical study of the Lattice Flow-Diverting Dense-Mesh Stent. It plans to enroll 280 patients, who will be treated for unruptured intracranial aneurysms using the Lattice Flow-Diverting Dense-Mesh Stent. Patients will be followed up at 12 months after device implantation, and data including the Raymond classification of the target aneurysms, the occurrence of complications, and whether complications result in neurological deficit symptoms will be collected and assessed. Through the above indicators, the clinical safety and efficacy of the product will be evaluated.
- Conditions
- Cerebral Aneurysm Unruptured
- Being tested
- Flow-Diverting Dense-Mesh Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow-Diverting Dense-Mesh StentDevice
Surface-Modified Flow-Diverting Dense-Mesh Stent for Mid-Term Follow-Up Study of Endovascular Embolization Therapy for Cerebral Aneurysms
What is being measured
The primary outcome is the main question the study is designed to answer.
Raymond-Roy Classification Scale
Raymond-Roy Classification Scale:
Grade I: Complete occlusion; Grade II: Near-complete occlusion (with residual aneurysm neck or dog-ear sign); Grade III: Partial occlusion (with residual aneurysm sac).
Measured: From Admission to the Hospital to 12 Months After the Completion of Surgical Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start24 Oct 2022
- Primary completion24 Oct 2022
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Aneurysm UnrupturedStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinjian Yang
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Beijing Chao Yang Hospital, Peking University International Hospital, Chinese PLA General Hospital
- Responsible party
- Sponsor-investigator, Xinjian Yang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190781
- Sponsor's protocol ID
- KY-2025-231-03
- Status last verified
- Aug 2025
- First submitted
- 17 Sep 2025
- Last updated
- 24 Sep 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 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development Platform Construction and Application Promotion of Drug-Eluting Stents for Intracranial Aneurysm Interventional Therapy
- ClinicalTrials.gov ID
- NCT07190781
- Acronym / sponsor ID
- KY-2025-231-03
- Conditions
- Cerebral Aneurysm Unruptured
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Xinjian YangUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Beijing Chao Yang Hospital, Peking University International Hospital, Chinese PLA General Hospital
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Sep 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.
This study is a post-marketing clinical study of the Lattice Flow-Diverting Dense-Mesh Stent. It plans to enroll 280 patients, who will be treated for unruptured intracranial aneurysms using the Lattice Flow-Diverting Dense-Mesh Stent. Patients will be followed up at 12 months after device implantation, and data including the Raymond classification of the target aneurysms, the occurrence of complications, and whether complications result in neurological deficit symptoms will be collected and assessed. Through the above indicators, the clinical safety and efficacy of the product will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with unruptured intracranial aneurysms via CTA , MRA , or DSA
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-Diverting Dense-Mesh StentSurface-Modified Flow-Diverting Dense-Mesh Stent for Mid-Term Follow-Up Study of Endovascular Embolization Therapy for Cerebral Aneurysms | Device | – |
Primary outcome
Raymond-Roy Classification Scale
Time frame: From Admission to the Hospital to 12 Months After the Completion of Surgical Treatment
Raymond-Roy Classification Scale: Grade I: Complete occlusion; Grade II: Near-complete occlusion (with residual aneurysm neck or dog-ear sign); Grade III: Partial occlusion (with residual aneurysm sac).
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 24 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cerebral Aneurysm Unruptured, run by Xinjian Yang 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?
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: enrolling by invitation, as of the sponsor's last update on 24 Sep 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?
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?
Raymond-Roy Classification Scale (time frame: From Admission to the Hospital to 12 Months After the Completion of Surgical Treatment). 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 24 Sep 2025.