The Flow Diverter for Treating Patients With Intracranial Aneurysms

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

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: the Flow Diverter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single arm<br>the patients will be treated by the trial device | Device: the Flow Diverter<br>* Those who meet the inclusion criteria but do not meet the exclusion criteria will be enrolled through the electronic central registration system. The investigator log in to the central registration system, fill in the subject information and submit it who enroll in the study. The investigator complete the surgery and conduct relevant evaluation according to the protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of complete aneurysm occlusion (Raymond score: Ⅰ) confirmed by 12 postoperative menstrual imaging | 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 | Twelve months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate postoperative success rate | 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. | Immediately after | 
| The parent artery was unblocked 12 months after surgery (stenosis rate ≤50%) and no further intervention was performed | 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 | Twelve months after surgery | 
| The rate of self-care (mRS 0-2 points) at 12 months after operation | MRS is a disability assessment to assess the independent living standard of postoperative patients and analyze the outcome of aneurysm surgery. | Twelve months after surgery |