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RecruitingNCT07376590Updated Jan 29, 2026

Multicenter Study to Evaluate the Effectiveness and Safety of Flow-Diverting Stents for Distal Intracranial Aneurysms

An observational study in Aneurysms, sponsored by First Affiliated Hospital of Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by First Affiliated Hospital of Zhejiang University · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
164
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Using data obtained from the treatment of intracranial distal intracranial aneurysms with flow diverter, evaluate the effecy and safety of blood flow diverter for the endovascular treatment of distal intracranial aneurysms.

02

Conditions studied

  • Aneurysms

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03

In context

Aneurysm

381 studies on the registry are indexed under Aneurysm; 78 are open to participants now.

This study's planned enrollment of 164 is close to the median of 157 across 132 observational studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 263 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

obtained from the treatment of intracranial distal intracranial aneurysms with flow diverter

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

  1. Age 18 to 80 years, any gender,Subjects who have accepted treatment with flow-diverting for distal intracranial aneurysms
  2. Diagnosed with an intracranial aneurysm by CTA, MRA, or DSA, with the following features: a wide neck (≥4mm), or a dome-to-neck ratio \<2, saccular, fusiform aneurysms, recurrent saccular aneurysms, and dissecting aneurysms. Locations include: the Circle of Willis and it's distal branches such as the middle cerebral artery (MCA) M1-M3 segments, anterior cerebral artery (ACA) A1-A3 segments, posterior cerebral artery (PCA) P1-P2 segments, etc. (intracranial aneurysms of the Circle of Willis and it's distal vessels).
  3. Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed form

Exclusion criteria

Exclusion Criteria:

  1. 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.)
  2. mRS score ≥3
  3. 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.)
  4. count \<60×10\^9/L, known platelet dysfunction, or (INR) >1.5
  5. Major surgery within 30 days before enrollment,or planned to undergo surgery within 360 days after enrollment
  6. Known allergies or to anesthetics, anticoagulants, and antiplatelet drugs
  7. Pregnant or breastfeeding women
  8. Subject has participated in other clinical trials within 1 month before signing
  9. Other conditions judged by the investigators as unsuitable for enrollment
Terms in these criteria, in plain language(4)

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.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
164 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Interventions

  • DeviceNo intervention measures

    No intervention measures, Using data obtained from the treatment of intracranial distal intracranial aneurysms with flow diverter, evaluate the effecy and safety of blood flow diverter for the endovascular treatment of distal intracranial aneurysms.

06

What researchers measure

Primary outcomes

  1. Complete occlusion rate of aneurysm 12 months after surgery

    Time frame: 12 months after surgery

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07376590
Responsible party
Sponsor
First posted
Jan 29, 2026
Start date
Jan 15, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jan 29, 2026

Study contacts

yuanyuan Shen
Contact
y.shen@zju.edu.cn
13958020971

Oversight

FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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