Intracranial AneurysmAPRESENTNCT07821957
A Multicenter Prospective Study of New Flow Diverter Stent on the Treatment of Intracranial Aneurysms in China
A study testing Novel Flow Diverter Stent in people with Intracranial Aneurysm, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Intracranial aneurysm, as a common cerebrovascular disease, has a variety of treatment methods, including surgical treatment and endovascular treatment. Among these treatment methods, flow diverters have attracted much attention due to their unique therapeutic principles. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Novel Flow Diverter Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2026to 31 Dec 2030
- Phase
- Interventional
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form and agreement to comply with protocol requirements.
- Age 22 to 80 years.
- Diagnosed with intracranial wide-neck aneurysm and planned for treatment with a flow diverter stent.
- Parent artery distal/proximal diameter compatible with available sizes and models of flow diverter stents, and treatment to be performed in accordance with the China NMPA-approved indications and instructions for use.
Who cannot join
- Need for treatment of another aneurysm in the affected territory of the target aneurysm using a different therapeutic modality during the study period.
- Prior intracranial implant (e.g., coils) in the target intracranial aneurysm territory within 6 months before enrollment.
- Prior surgery, including endovascular treatment, within 30 days before enrollment.
- Modified Rankin Scale (mRS) score ≥ 3.
- Any known contraindication to flow diverter stent treatment or antiplatelet therapy, including contraindications to dual antiplatelet therapy (DAPT).
- Pre-existing stent/flow diverter placed in the parent artery of the target aneurysm location.
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- Investigator judges that the patient's health or the validity of study results (e.g., high risk of neurological events, conditions that may increase the chance of stroke) could be compromised by study participation.
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- Known allergy to platinum or cobalt-chromium alloys (including major elements: platinum, cobalt, chromium, nickel, or molybdenum).
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
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Hengwei Jin, 15001189679, jinhengwei123@163.com
About this study
Intracranial aneurysm, as a common cerebrovascular disease, has a variety of treatment methods, including surgical treatment and endovascular treatment. Among these treatment methods, flow diverters have attracted much attention due to their unique therapeutic principles. Flow diverters help promote thrombus formation within the aneurysm by altering the direction and dynamics of blood flow, thereby achieving the purpose of treatment. 1-5 Flow diverters such as the Pipeline™ device have been proven to be safe and effective for the treatment of intracranial aneurysms and have gradually been recognized as the preferred device for the management of intracranial aneurysms.
- Conditions
- Intracranial Aneurysm
- Being tested
- Novel Flow Diverter Stent
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Flow Diverter StentDevice
Patients with intracranial wide-neck aneurysms undergo implantation of new generation flow diverter stents (e.g., Pipeline Shield, Lattice, etc.) per IFU and local practice. Stent reconstructs parent artery, diverts flow, promoting aneurysm thrombosis. Concomitant antiplatelet therapy (DAPT: aspirin + clopidogrel/ticagrelor) given per guidelines, continued ≥3-6 months post-procedure. This is a prospective, multicenter, single-arm, real-world study in China (≈15 sites, N=280). Follow-up: 30d, 6m, 1y, then annually to 4y post-procedure, including clinical (mRS) and imaging (DSA/CTA) assessments.
| Study group | Role | What they receive |
|---|---|---|
| Flow Diverter Stent Treatment Group | Experimental | Not described Receives: Device: Novel Flow Diverter Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm Complete Occlusion Rate
Proportion of patients with complete occlusion of the target aneurysm at 1 year post-procedure, as assessed by the core imaging laboratory using the Raymond-Roy Occlusion Classification (Class I: complete obliteration).
Measured: 1 year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start6 Jan 2026
- Primary completion29 Aug 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital, Peking University International Hospital, Beijing Chao Yang Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821957
- Sponsor's protocol ID
- KY2025-190-03
- Other IDs
- 2025-3098-YXZX-0483
- Acronym
- APRESENT
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aoki T, Nozaki K. Preemptive Medicine for Cerebral Aneurysms. Neurol Med Chir (Tokyo). 2016 Sep 15;56(9):552-68. doi: 10.2176/nmc.st.2016-0063. Epub 2016 Apr 6.
PubMed 27053328Al-Mufti F, Amuluru K, Gandhi CD, Prestigiacomo CJ. Flow Diversion for Intracranial Aneurysm Management: A New Standard of Care. Neurotherapeutics. 2016 Jul;13(3):582-9. doi: 10.1007/s13311-016-0436-4.
PubMed 27160270
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Study of New Flow Diverter Stent on the Treatment of Intracranial Aneurysms in China
- ClinicalTrials.gov ID
- NCT07821957
- Acronym / sponsor ID
- APRESENT / KY2025-190-03
- Conditions
- Intracranial Aneurysm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Huashan Hospital, Peking University International Hospital, Beijing Chao Yang Hospital
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 29 Aug 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Sep 2026 (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.
Intracranial aneurysm, as a common cerebrovascular disease, has a variety of treatment methods, including surgical treatment and endovascular treatment. Among these treatment methods, flow diverters have attracted much attention due to their unique therapeutic principles. Flow diverters help promote thrombus formation within the aneurysm by altering the direction and dynamics of blood flow, thereby achieving the purpose of treatment. 1-5 Flow diverters such as the Pipeline™ device have been proven to be safe and effective for the treatment of intracranial aneurysms and have gradually been recognized as the preferred device for the management of intracranial aneurysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flow Diverter Stent Treatment Group | Experimental | Device: Novel Flow Diverter Stent |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent form and agreement to comply with protocol requirements.
- Age 22 to 80 years.
- Diagnosed with intracranial wide-neck aneurysm and planned for treatment with a flow diverter stent.
- Parent artery distal/proximal diameter compatible with available sizes and models of flow diverter stents, and treatment to be performed in accordance with the China NMPA-approved indications and instructions for use.
Key exclusion criteria (9 listed)
- Need for treatment of another aneurysm in the affected territory of the target aneurysm using a different therapeutic modality during the study period.
- Prior intracranial implant (e.g., coils) in the target intracranial aneurysm territory within 6 months before enrollment.
- Prior surgery, including endovascular treatment, within 30 days before enrollment.
- Modified Rankin Scale (mRS) score ≥ 3.
- Any known contraindication to flow diverter stent treatment or antiplatelet therapy, including contraindications to dual antiplatelet therapy (DAPT).
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 |
|---|---|---|
| Novel Flow Diverter StentPatients with intracranial wide-neck aneurysms undergo implantation of new generation flow diverter stents (e.g., Pipeline Shield, Lattice, etc.) per IFU and local practice. Stent reconstructs parent artery, diverts flow, promoting aneurysm thrombosis. Concomitant antiplatelet therapy (DAPT: aspirin + clopidogrel/ticagrelor) given per guidelines, continued ≥3-6 months post-procedure. This is a prospective, multicenter, single-arm, real-world study in China (≈15 sites, N=280). Follow-up: 30d, 6m, 1y, then annually to 4y post-procedure, including clinical (mRS) and imaging (DSA/CTA) assessments. | Device | Flow Diverter Stent Treatment Group |
Primary outcome
Aneurysm Complete Occlusion Rate
Time frame: 1 year post-procedure
Proportion of patients with complete occlusion of the target aneurysm at 1 year post-procedure, as assessed by the core imaging laboratory using the Raymond-Roy Occlusion Classification (Class I: complete obliteration).
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 16 Sep 2026.
- Background: PubMed 27053328Aoki T, Nozaki K. Preemptive Medicine for Cerebral Aneurysms. Neurol Med Chir (Tokyo). 2016 Sep 15;56(9):552-68. doi: 10.2176/nmc.st.2016-0063. Epub 2016 Apr 6.
- Background: PubMed 27160270Al-Mufti F, Amuluru K, Gandhi CD, Prestigiacomo CJ. Flow Diversion for Intracranial Aneurysm Management: A New Standard of Care. Neurotherapeutics. 2016 Jul;13(3):582-9. doi: 10.1007/s13311-016-0436-4.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Flow Diverter Stent in people with Intracranial Aneurysm, run by Beijing Tiantan 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 4 inclusion and 9 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 16 Sep 2026. 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 Hengwei Jin (15001189679, jinhengwei123@163.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 (time frame: 1 year post-procedure). 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 NCT07821957, which also lists 2 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 16 Sep 2026.