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| Name | Class |
|---|---|
| Xuanwu Hospital, Beijing | OTHER |
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The primary objective of this trial is to evaluate the safety and efficacy of the cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms
The investigation is a prospective, multi-center, single arm clinical study. The trial is anticipated to last from March 2023 to January 2025 with 143 subjects recruited in around 10 China centers. The population for this study is subjects with wide-necked intracranial aneurysms who are suitable candidates for flow diverter implantation. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after offering informed consent form. The study consists of six visits including preoperative screening, operation date, 7days or at discharge, 30 days, 180 days, and 1 year. The primary efficacy endpoint was complete aneurysm occlusion with parent artery stenosis ≤ 50% at one year post-procedure in the absence of additional treatments, while the primary safety endpoint was no major stroke in the treated artery territory or neurological death at one year post-procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebral flow diverter | Experimental | The cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebral flow diverter | Device | The surface-modified flow diverter is an intracranial implant designed to be placed in a parent artery so as to divert blood flow away from an aneurysm. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 1 year post procedure | Proportion of subjects with complete occlusion of the target aneurysm, ≤50% stenosis of the parent artery at the target cerebral aneurysms at 1 year as assessed by angiography, and in whom an unplanned alternative treatment of the target cerebral aneurysms had not been performed within 1 year. | 1 year post procedure |
| Major stroke in the territory supplied by the treated artery or neurological death at 1 year post procedure | National Institute of Health Stroke Scale (NIHSS) was used to assess patients after stroke in an 11-item scale with potential scores ranging from 0 to 42. Higher values represent a worse outcome. A major stroke is defined as a new neurological event which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the NIHSS as compared to baseline. | 1 year post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate procedural success rate | Intraoperative cerebrovascular imaging is performed to determine whether the investigational device positions exactly and covers the aneurysm neck effectively. | Intra-procedure |
| Complete aneurysm occlusion rate at 180 days and 1 year post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongqi Zhang, Ph.D | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Capital Medical University | Beijing | China |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Complete occlusion was defined as complete obliteration of the aneurysm sac, including the neck (Raymond I). |
| 180 days, 1 year post procedure |
| Success aneurysm occlusion at 180 days and 1 year post procedure | The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Success aneurysm occlusion in which class 1 or 2 is achieved on the Raymond Scale at the 180 days and 1 year follow-up angiographic assessments will be evaluated. | 180 days and 1 year post procedure |
| Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 180 days post procedure | Proportion of subjects with complete occlusion of the target aneurysm, ≤50% stenosis of the parent artery at the target cerebral aneurysms at 180 days as assessed by angiography, and in whom an unplanned alternative treatment of the target cerebral aneurysms had not been performed within 180 days. | 180 days post procedure |
| All-cause mortality at 30 days, 180 days and 1 year post procedure | Deaths due to any cause are calculated. | 30 days, 180 days and 1 year post procedure |
| Any stroke at 30 days, 180 days and 1 year post procedure | Incidence of any stroke including ischemic and hemorrhagic stroke. | 30 days, 180 days and 1 year post procedure |
| Major stroke in the territory supplied by the treated artery or neurological death at 180 days post procedure | National Institute of Health Stroke Scale (NIHSS) was used to assess patients after stroke in an 11-item scale with potential scores ranging from 0 to 42. Higher values represent a worse outcome. A major stroke is defined as a new neurological event which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the NIHSS as compared to baseline. | 180 days post procedure |
| Target aneurysmal hemorrhage at 180 days and 1 year post procedure | Percentage (%) of participants who experienced a Target aneurysmal hemorrhage. | 180 days and 1 year post procedure |
| Ischemic cerebrovascular events caused by thromboembolism at 180 days and 1 year post procedure | Percentage (%) of participants who experienced ischemic cerebrovascular events caused by thromboembolism. | 180 days and 1 year post procedure |
| Incidence of operation or device-related adverse events/serious adverse events during hospitalization, 30 days, 180 days and 1 year post procedure | Percentage (%) of participants who experienced adverse events/serious adverse events. | hospitalization, 30 days, 180 days and 1 year post procedure |
| Rate of Device defect | Device defects refer to the unreasonable risks that may endanger human health and life safety during the normal use of medical devices in the course of clinical trials, such as label errors, quality problems, failures, etc. | within 1 year of whole trial |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |