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Cerebral AneurysmNCT05774782

Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modification

A study testing Cerebral flow diverter in people with Cerebral Aneurysm and Cerebral Aneurysm Unruptured, run by Sinomed Neurovita Technology Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this trial is to evaluate the safety and efficacy of the cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Cerebral flow diverter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
1 siteChina
Study dates
27 Mar 2023to 30 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years to 75 years, male or non-pregnant female.
  • Unruptured wide-necked cerebral aneurysms confirmed by preoperative imaging (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio < 2).
  • Parent vessel with a diameter range of 1.75-6.0 mm.
  • Those who voluntarily participate in the study and sign informed consent form.

Who cannot join

  • Subject with target aneurysms are blood blister-like aneurysms, pseudoaneurysms, arteriovenous malformation, moyamoya disease-related aneurysm, or multiple aneurysms that cannot be treated with a single stent.
  • Severe arteriosclerosis or tortuosity of intracranial artery, and the device is difficult to reach the target vessel.
  • Subject with target aneurysm previously treated with craniotomy or other endovascular interventional therapy.
  • Known sensitivity to antiplatelet medications, anticoagulant medications, radiographic contrast agents, anesthetic, nickel, platinum-tungsten alloy, platinum-iridium alloy, and poly-N-[Tris(hydroxymethyl)methyl] acrylamide (poly-NTMA).
  • Severe respiratory system, liver and kidney diseases (such as creatinine ≥ 3.0 mg/dL (except dialysis)) or blood coagulation disorders before operation.
  • Platelet count is less than 100×109/L, international normalized ratio (INR) is more than 1.5.
Show all 11Show fewer
  • Hospitalized surgical treatment within the previous 30 days or planned within the next 180 days after operation.
  • Severe neurological deficit that renders the patient incapable of living independently (modified Rankin score ≥3).
  • The survival expectation is less than 1 year.
  • All subjects who are participating in other drug/medical device clinical trials and have not completed the programme requirements
  • Inapplicable for this study at the investigators' viewpoints.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuanwu Hospital Capital Medical University

    Beijing

Other trials in China

About this study

Official title: A Prospective, Multi-center, Single Arm Clinical Study to Evaluate the Safety and Effectiveness of the Flow Diverter Stent System in the Treatment of Cerebral Aneurysms

The primary objective of this trial is to evaluate the safety and efficacy of the cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms

Read the detailed description

The investigation is a prospective, multi-center, single arm clinical study. The trial is anticipated to last from March 2023 to January 2025 with 143 subjects recruited in around 10 China centers. The population for this study is subjects with wide-necked intracranial aneurysms who are suitable candidates for flow diverter implantation. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after offering informed consent form. The study consists of six visits including preoperative screening, operation date, 7days or at discharge, 30 days, 180 days, and 1 year. The primary endpoint was successful aneurysm occlusion at one year post-procedure.

Being tested
Cerebral flow diverter
Keywords
flow diverter, endovascular therapy
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cerebral flow diverterDevice

    The surface-modified flow diverter is an intracranial implant designed to be placed in a parent artery so as to divert blood flow away from an aneurysm.

Study groups in NCT05774782
Study groupRoleWhat they receive
Cerebral flow diverterExperimentalThe cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms
Receives: Device: Cerebral flow diverter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful aneurysm occlusion at 1 year post procedure

    The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Successful aneurysm occlusion in which class 1 or 2 is achieved on the Raymond Scale at one year follow-up angiographic assessments will be evaluated.

    Measured: 1 year post procedure

Secondary outcomes (11)

  1. Immediate procedural success rate

    Intraoperative cerebrovascular imaging is performed to determine whether the investigational device positions exactly and covers the aneurysm neck effectively.

    Measured: Intra-procedure

  2. Complete aneurysm occlusion rate at 180 days and 1 year post procedure

    Complete occlusion was defined as complete obliteration of the aneurysm sac, including the neck (Raymond I).

    Measured: 180 days, 1 year post procedure

  3. Successful aneurysm occlusion at 180 days post procedure

    The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Successful aneurysm occlusion in which class 1 or 2 is achieved on the Raymond Scale at the 180 days follow-up angiographic assessments will be evaluated.

    Measured: 180 days post procedure

  4. Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 180 days and 1 year post procedure

    Proportion of subjects with complete occlusion of the target aneurysm, ≤50% stenosis of the parent artery at the target cerebral aneurysms at 180 days and 1 year as assessed by angiography, and in whom an unplanned alternative treatment of the target cerebral aneurysms had not been performed within 180 days and 1 year.

    Measured: 180 days and 1 year post procedure

  5. All-cause mortality at 30 days, 180 days and 1 year post procedure

    Deaths due to any cause are calculated.

    Measured: 30 days, 180 days and 1 year post procedure

  6. Any stroke at 30 days, 180 days and 1 year post procedure

    Incidence of any stroke including ischemic and hemorrhagic stroke.

    Measured: 30 days, 180 days and 1 year post procedure

  7. Major stroke in the territory supplied by the treated artery or neurological death at 180 days and 1 year post procedure

    National Institute of Health Stroke Scale (NIHSS) was used to assess patients after stroke in an 11-item scale with potential scores ranging from 0 to 42. Higher values represent a worse outcome. A major stroke is defined as a new neurological event which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the NIHSS as compared to baseline.

    Measured: 180 days and 1 year post procedure

  8. Target aneurysmal hemorrhage at 180 days and 1 year post procedure

    Percentage (%) of participants who experienced a Target aneurysmal hemorrhage.

    Measured: 180 days and 1 year post procedure

  9. Ischemic cerebrovascular events caused by thromboembolism at 180 days and 1 year post procedure

    Percentage (%) of participants who experienced ischemic cerebrovascular events caused by thromboembolism.

    Measured: 180 days and 1 year post procedure

  10. Incidence of operation or device-related adverse events/serious adverse events during hospitalization, 30 days, 180 days and 1 year post procedure

    Percentage (%) of participants who experienced adverse events/serious adverse events.

    Measured: hospitalization, 30 days, 180 days and 1 year post procedure

  11. Rate of Device defect

    Device defects refer to the unreasonable risks that may endanger human health and life safety during the normal use of medical devices in the course of clinical trials, such as label errors, quality problems, failures, etc.

    Measured: within 1 year of whole trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2023
  2. Study start27 Mar 2023
  3. Primary completion23 Jun 2024
  4. Study completion30 Aug 2024

Resources

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
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05774782
Sponsor's protocol ID
SNSC-CFD-202204
Status last verified
Jul 2026
First submitted
6 Mar 2023
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Cerebral flow diverter in people with Cerebral Aneurysm and Cerebral Aneurysm Unruptured, run by Sinomed Neurovita Technology Inc. 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 11 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: finished, as of the sponsor's last update on 13 Jul 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Successful aneurysm occlusion at 1 year post procedure (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 NCT05774782.

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 13 Jul 2026.

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