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This trial was designed as a prospective, multicentre, open, non-inferiority, randomised controlled clinical trial, with the control devices being MicroVention's LVIS Intraluminal Support Device and LVIS Jr. Intraluminal Support Device. Approximately 200 subjects with intracranial aneurysms would be enrolled for stent-assisted coiling embolisation according to the inclusion and exclusion criteria specified in this trial protocol. Subjects were evaluated by mRS preoperatively, at the time of device implantation, at the time of discharge from the hospital, at 1 month (±7 days) postoperatively, at 6 months (±30 days) postoperatively, and at 12 months (±60 days) postoperatively; subjects would underwent DSA imaging at surgery and at 6 months (±30 days) postoperatively, and MRA or DSA imaging at 12 months (±60 days) postoperatively. Unplanned follow-up of the subjects would performed when necessary, and data would be recorded to evaluate the safety and efficacy of intracranial artery stent for stent-assisted coiling embolisation for the treatment of intracranial aneurysms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Microport NeuroTech Intracranial Visualized Stent |
|
| Control group | Active Comparator | LVIS™ and LVIS™ Jr |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracranial stent for wide-necked aneurysms | Device | Intracranial stent for wide-necked aneurysms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of aneurysms with adequate occlusion | The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion postoperatively or at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete occlusion; Class II: residual neck; Class III: residual aneurysm. Adequate occlusion rate includes Class I and Class II | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of stent technical success | Technical successwas defined as the stent was successfully released at the appropriate position, and covered the aneurysm's neck completely while the parent artery remained unobstructed postoperatively. | immediately after the procedure |
| Rate of aneurysms with complete occlusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huina Lu | Contact | 15901703529 | HuiNa.Lu@microport.com |
| Name | Affiliation | Role |
|---|---|---|
| sheng guan | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | China |
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| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D000783 | Aneurysm |
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion postoperatively or at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete occlusion; Class II: residual neck; Class III: residual aneurysm. Complete occlusion rate includes Class I |
| 6 months |
| Rate of in-stent stenosis (≥50%) | 6 months |
| Rate of aneurysms with adequate occlusion | 1 year |
| Rate of aneurysms with complete occlusion | 1 year |
| Rate of aneurysms with retreatment | Percentage of subjects who had aneurysm recurrence and underwent a secondary suergry during follow-up | 1 year |
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |