The Flow Diverter for Treating Patients With Intracranial Aneurysms

Not Applicable

• Conditions: Intracranial Aneurysm
• Interventions: Device: the Flow Diverter

• Registration Number: NCT05060185
• Lead Sponsor: Jiangsu CED Medtech Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-27
• Last Update Submitted: 2021-09-27
• Study First Posted: 2021-09-29
• Last Update Posted: 2021-09-29
• Study Start: 2021-10-17
• Primary Completion: 2024-02-28
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 166

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	the Flow Diverter	the patients will be treated by the trial device

Primary Outcome Measures

Name	Time	Method
The rate of complete aneurysm occlusion (Raymond score: Ⅰ) confirmed by 12 postoperative menstrual imaging	Twelve months after surgery	The cerebral vascular imaging examination 12 months after the operation was performed to analyze whether the aneurysm was completely occluded. Aneurysm occlusion images were reviewed by clinicians and the core laboratory respectively. When the evaluation results were different from those determined by clinicians, the results of the core laboratory should prevail

Secondary Outcome Measures

Name	Time	Method
Immediate postoperative success rate	Immediately after	The intraoperative blood flow guidance device was successfully released, and the implant was accurately located by angiography after placement, and the proportion of subjects who could effectively cover aneurysma neck was calculated.
The parent artery was unblocked 12 months after surgery (stenosis rate ≤50%) and no further intervention was performed	Twelve months after surgery	The clinician and the core laboratory will evaluate the results respectively. If the evaluation results are different from those determined by the clinician, the core laboratory results shall prevail
The rate of self-care (mRS 0-2 points) at 12 months after operation	Twelve months after surgery	MRS is a disability assessment to assess the independent living standard of postoperative patients and analyze the outcome of aneurysm surgery.