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
The scope of this trial is the collection and analysis of effectiveness and safety endpoints, related to the use of the Bioabsorbable/Nufairy Coil Embolization System in the treatment of intracranial aneurysms.
Approximately 258 subjects with intracranial aneurysms would be enrolled for coiling embolization 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 (±90 days) postoperatively; subjects would underwent DSA imaging at surgery and at 12months (±90 days) postoperatively, and MRA imaging at 18 months (±90 days) postoperatively. Unplanned follow-up of the subjects would performed when necessary, and data would be recorded to evaluate the safety and efficacy of Nufairy Coil Embolization System for coiling embolization for the treatment of intracranial aneurysms.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Bioabsorbable/Nufairy coil embolization system |
|
| Control group | Active Comparator | Numen coil embolization system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nufairy® Coil embolization system for intracranial aneurysm | Device | Nufairy® Coil embolization system for intracranial aneurysm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful occlusion rate of aneurysm at 12-month post-procedure. | It was defined as the percentage of subjects with the degree of aneurysm embolization scored as Raymond I or II (i.e., 95%-100% aneurysm embolization). | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Complete occlusion rate of aneurysm at 12-month post-procedure. | The "complete occlusion rate of aneurysm" was defined as the percentage of subjects with the degree of aneurysm embolization scored as Raymond I (i.e., 100% aneurysm embolization). | 12 month |
| Recurrence rate of aneurysm at 12-month post-procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful occlusion rate of aneurysm at 18-month post-procedure. | It was defined as the percentage of subjects with the degree of aneurysm embolization scored as Raymond I or II (i.e., 95%-100% aneurysm embolization). | 18 month |
| Recurrence rate of aneurysm at 18-month post-procedure. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jianmin Liu | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changhai Hospital | Shanghai | China |
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 "recurrence rate of aneurysm" was defined as the percentage of subjects with a decrease in the degree of aneurysm embolization at the follow-up visit as compared with immediately post-procedure. |
| 12 month |
| Retreatment rate of aneurysm at 12-month post-procedure. | The "retreatment of aneurysm" was defined as the percentage of subject who received retreatment for the recurrence of target aneurysms during the follow-up period | 12 month |
| Device-related serious adverse events at 1, 6, and 12 months after surgery; | 12 month |
| The incidence of ipsilateral stroke or neurologic death of the target aneurysm within 12 months. | 12 month |
| The incidence of ipsilateral ischemic stroke of the target aneurysm within 12 months. | 12 month |
The "recurrence rate of aneurysm" was defined as the percentage of subjects with a decrease in the degree of aneurysm embolization at the follow-up visit as compared with immediately post-procedure. |
| 18 month |
| Retreatment rate of aneurysm at 18-month post-procedure. | The "retreatment of aneurysm" was defined as the percentage of subject who received retreatment for the recurrence of target aneurysms during the follow-up period | 18 month |
| The incidence of ipsilateral stroke or neurologic death of the target aneurysm within 18 months. | 18 month |
| Device-related serious adverse events at 18 months after surgery | 18 month |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |