NCT06943729

Brief Summary

To collect the safety and effectiveness data of flow-di in the treatment of intracranial aneurysms in real-world clinical practice, verify its classification of treatment strategies for aneurysms of different locations and shapes, and optimize postoperative medication regimen, provide long-term evidence-based basis for clinical treatment of intracranial aneurysms, and build a database.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
523

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Apr 2025Apr 2027

First Submitted

Initial submission to the registry

April 14, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

April 27, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

1.7 years

First QC Date

April 14, 2025

Last Update Submit

August 22, 2025

Conditions

Flow Diverter

Keywords

Flow DiverterIntracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Aneurysm complete occlusion rate 12 months after surgery

    12 months after surgery

Secondary Outcomes (8)

  • Aneurysm complete occlusion rate 6 months after surgery

    6 months after surgery

  • Immediate success rate

    Immediate

  • In-stent stenosis (>50% stenosis) rate 6,12 months after surgery

    6,12 months after surgery

  • Incidence of ipsilateral disabled stroke 3 months after surgery, 6 months after surgery, and 12 months after surgery

    3 months after surgery, 6 months after surgery, and 12 months after surgery

  • neurogenic death rate 6 months and 12 months after surgery

    6 months and 12 months after surgery

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

intracranial aneurysm diagnosed by CTA, MRA or DSA (Including wide-necked aneurysms (neck width ≥4mm or Dome/neck ratio \<2), saccular, fusiform aneurysms, recurrent saccular aneurysms and dissecting aneurysms, and the diameter of the parent vessel ≥ 2.0 mm and ≤ 6.0 mm

You may qualify if:

  • )18 years ≤80 years; 2) intracranial aneurysm diagnosed by CTA, MRA or DSA (Including wide-necked aneurysms (neck width ≥4mm or Dome/neck ratio \<2), saccular, fusiform aneurysms, recurrent saccular aneurysms and dissecting aneurysms, and the diameter of the parent vessel ≥ 2.0 mm and ≤ 6.0 mm; the location includes: anterior circulation C3 segment and above of internal carotid artery, distal artery of Willis circle, posterior circulation V4 segment of vertebral artery and basilar artery and its main branches; 3) Voluntary participation in this study and signing of the Informed Consent Form (ICF).

You may not qualify if:

  • )AVM related aneurysm; 2) Acute ruptured aneurysm; 3) Severe stenosis or tortuosity of intracranial artery, or anatomical abnormality, which makes it difficult for the device to reach the lesion ; 4) Patients with hemorrhagic or ischemic stroke within 30 days; 5) Modified Rankin Score (mRS)\>2 points before operation; 6) Patients with life expectancy less than 12 months; 7) Patients with definite history of allergy to cobalt-chromium alloy and platinum-tungsten alloy materials; Allergy to contrast media; 8) antiplatelet (PLT)\<100×10\^ 9 /L or/and anticoagulation contraindicated; 9) pregnant or lactating women; 10) other study participants who were assessed by the investigator as unsuitable for participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Gu Yuxiang, PhD

    department of Neurosurgery, Huashan Hospital,Fudan University

    STUDY CHAIR

Central Study Contacts

Gao Chao, PhD

CONTACT

18916960799gc_huashanneuro@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-president of Huashan Hospital west campus

Study Record Dates

First Submitted

April 14, 2025

First Posted

April 24, 2025

Study Start

April 27, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)