ClinicalTrials.gg
RecruitingNCT07821957APRESENTUpdated Sep 16, 2026

A Multicenter Prospective Study of New Flow Diverter Stent on the Treatment of Intracranial Aneurysms in China

An interventional study of Novel Flow Diverter Stent in Intracranial Aneurysm, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 22 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2026, registered Sep 2026).
  • Started Jan 2026; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Not applicable
Ages
22 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Intracranial Aneurysm by Beijing Tiantan Hospital — 7 open to participants now, 8 under way, 1 of them phase 3. Intracranial Aneurysm · Beijing Tiantan Hospital.

Started
2026
the only one that year
No phase
5 of 20
2 open now
Registered
19th of 20
by date

Among the 20 studies in Intracranial Aneurysm by Beijing Tiantan Hospital, this one is the only one that started in 2026, is one of 5 with no phase, and was the 19th registered.

Intracranial Aneurysm

418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.

Browse Intracranial Aneurysm studies →

Open to participants now

7 of the 20 studies in Intracranial Aneurysm by Beijing Tiantan Hospital are open now, in 1 country. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 82 Intracranial Aneurysm studies recruiting now, 49 (60%) set no upper age limit and 14 (17%) stop at 75 or younger; 15 take children under 18; 6 take healthy volunteers.

This study: 22 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Intracranial Aneurysm

Browse trials for

04

Who can participate

Ages eligible
22 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed 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.

Exclusion criteria

Exclusion Criteria:

  • 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 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.

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).

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
280 participants (estimated)

Study arms

  • Experimental
    Flow Diverter Stent Treatment Group

    Device: Novel Flow Diverter Stent

Interventions

  • DeviceNovel Flow Diverter Stent

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 1 year post-procedure

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 27053328 ↗
  • Al-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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Aug 2030, 55 months after the start.

Of 56 non-industry interventional studies with no phase under Intracranial Aneurysm, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 134. This study's planned 55 months is close to that.

Counting every sponsor, half of 104 studies reached it within 39 months; a quarter within 22 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2026
First posted
Sep 16, 2026
StartActual
Jan 6, 2026
Primary completionEst.
Aug 29, 2030
CompletionEst.
Dec 31, 2030
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07821957
Collaborators
Huashan Hospital, Peking University International Hospital, Beijing Chao Yang Hospital
Responsible party
Sponsor
First posted
Sep 16, 2026
Start date
Jan 6, 2026
Primary completion
Aug 29, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Sep 16, 2026

Study contacts

Hengwei Jin
Contact
jinhengwei123@163.com
15001189679

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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