Suspended

A Prospective, Multicenter,Single Arm Clinical Investigation Evaluating Safety and Effectiveness of the Flow Diverter for Treating Patients With Intracranial Aneurysms

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What is being tested

the Flow Diverter

Device
Who is being recruted

Aneurysm+6

+ Brain Diseases

+ Cardiovascular Diseases

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2021
See protocol details

Summary

Principal SponsorJiangsu CED Medtech Co., Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 17, 2021

Actual date on which the first participant was enrolled.

To evaluate the efficacy and safety of the blood flow guide device manufactured by Jiangsu Changyida Medical Technology Co., Ltd. for endovascular embolization of intracranial aneurysms

Official TitleA Prospective, Multicenter,Single Arm Clinical Investigation Evaluating Safety and Effectiveness of the Flow Diverter for Treating Patients With Intracranial Aneurysms
NCT05060185
Principal SponsorJiangsu CED Medtech Co., Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

166 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AneurysmBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesIntracranial AneurysmCerebrovascular DisordersNervous System DiseasesVascular DiseasesIntracranial Arterial Diseases

Criteria

Inclusion Criteria: ●≥18 years old and ≤75 years old, male or unpregnant female * Untreated and unruptured intracranial wide-necked aneurysm confirmed by preoperative imaging diagnosis (wide-necked aneurysm was defined as the tumor neck ≥4mm or the tumor body/tumor neck ratio \<2) * The target aneurysm is planned to be treated with blood flow guidance device only, without the need to complete the treatment by stages * The width of tumor neck should be less than 30mm * Imaging measurements of the tumor parent artery showed that the diameter was 1.5mm \~ 6.5mm * The subject or legal guardian can understand the purpose of the study, demonstrate sufficient compliance with the study protocol, and sign the informed consent Exclusion Criteria: * The target aneurysm has previously received craniotomy clipping or other endovascular interventional treatment * Target aneurysms were haemacular aneurysms, pseudoaneurysms, arteriovenous malformations and moyamoya disease related aneurysms * DSA suggested vascular path tortuosity or severe arteriosclerosis, and it was difficult for the instrument to reach the target vessel * Contraindications to dual antiplatelet therapy and anticoagulation therapy * Patients with known clear allergy to nickel-titanium alloys and platinum-tungsten alloys * People with known severe allergy to contrast media (excluding rash) * patients with known dementia or mental illness * Preoperative complicated with serious heart, liver, kidney, respiratory system diseases and bleeding disorders * Life expectancy is less than one year * Is participating in, or may participate in, any other drug or medical device clinical trial after inclusion in this clinical trial * Other conditions determined by the investigator to be unsuitable for participation in this clinical trial

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

the patients will be treated by the trial device

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers