A Prospective, Multicenter,Single Arm Clinical Investigation Evaluating Safety and Effectiveness of the Flow Diverter for Treating Patients With Intracranial Aneurysms
the Flow Diverter
Aneurysm+6
+ Brain Diseases
+ Cardiovascular Diseases
Treatment Study
Summary
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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.166 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives