Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Other | the patients will be treated by the trial device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the Flow Diverter | Device | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
●≥18 years old and ≤75 years old, male or unpregnant female
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |