Cerebral Aneurysm, Cerebral Aneurysm Unruptured
Conditions
Keywords
flow diverter, endovascular therapy
Brief summary
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
Detailed description
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 endpoint was successful aneurysm occlusion at one year post-procedure.
Interventions
DEVICECerebral flow diverter
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.
Sponsors
Sinomed Neurovita Technology Inc.
Xuanwu Hospital, Beijing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 years to 75 years, male or non-pregnant female. 2. Unruptured wide-necked cerebral aneurysms confirmed by preoperative imaging (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio \< 2). 3. Parent vessel with a diameter range of 1.75-6.0 mm. 4. Those who voluntarily participate in the study and sign informed consent form.
Exclusion criteria
1. Subject with target aneurysms are blood blister-like aneurysms, pseudoaneurysms, arteriovenous malformation, moyamoya disease-related aneurysm, or multiple aneurysms that cannot be treated with a single stent. 2. Severe arteriosclerosis or tortuosity of intracranial artery, and the device is difficult to reach the target vessel. 3. Subject with target aneurysm previously treated with craniotomy or other endovascular interventional therapy. 4. Known sensitivity to antiplatelet medications, anticoagulant medications, radiographic contrast agents, anesthetic, nickel, platinum-tungsten alloy, platinum-iridium alloy, and poly-N-\[Tris(hydroxymethyl)methyl\] acrylamide (poly-NTMA). 5. Severe respiratory system, liver and kidney diseases (such as creatinine ≥ 3.0 mg/dL (except dialysis)) or blood coagulation disorders before operation. 6. Platelet count is less than 100×109/L, international normalized ratio (INR) is more than 1.5. 7. Hospitalized surgical treatment within the previous 30 days or planned within the next 180 days after operation. 8. Severe neurological deficit that renders the patient incapable of living independently (modified Rankin score ≥3). 9. The survival expectation is less than 1 year. 10. All subjects who are participating in other drug/medical device clinical trials and have not completed the programme requirements 11. Inapplicable for this study at the investigators' viewpoints.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful aneurysm occlusion at 1 year post procedure | 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 Successful aneurysm occlusion in which class 1 or 2 is achieved on the Raymond Scale at one year follow-up angiographic assessments will be evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate procedural success rate | Intra-procedure | Intraoperative cerebrovascular imaging is performed to determine whether the investigational device positions exactly and covers the aneurysm neck effectively. |
| Complete aneurysm occlusion rate at 180 days and 1 year post procedure | 180 days, 1 year post procedure | Complete occlusion was defined as complete obliteration of the aneurysm sac, including the neck (Raymond I). |
| Successful aneurysm occlusion at 180 days post procedure | 180 days 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 Successful aneurysm occlusion in which class 1 or 2 is achieved on the Raymond Scale at the 180 days follow-up angiographic assessments will be evaluated. |
| Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 180 days and 1 year post procedure | 180 days and 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 180 days and 1 year as assessed by angiography, and in whom an unplanned alternative treatment of the target cerebral aneurysms had not been performed within 180 days and 1 year. |
| All-cause mortality at 30 days, 180 days and 1 year post procedure | 30 days, 180 days and 1 year post procedure | Deaths due to any cause are calculated. |
| Any stroke at 30 days, 180 days and 1 year post procedure | 30 days, 180 days and 1 year post procedure | Incidence of any stroke including ischemic and hemorrhagic stroke. |
| Major stroke in the territory supplied by the treated artery or neurological death at 180 days and 1 year post procedure | 180 days and 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. |
| Target aneurysmal hemorrhage at 180 days and 1 year post procedure | 180 days and 1 year post procedure | Percentage (%) of participants who experienced a Target aneurysmal hemorrhage. |
| Ischemic cerebrovascular events caused by thromboembolism at 180 days and 1 year post procedure | 180 days and 1 year post procedure | Percentage (%) of participants who experienced ischemic cerebrovascular events caused by thromboembolism. |
| Incidence of operation or device-related adverse events/serious adverse events during hospitalization, 30 days, 180 days and 1 year post procedure | hospitalization, 30 days, 180 days and 1 year post procedure | Percentage (%) of participants who experienced adverse events/serious adverse events. |
| Rate of Device defect | within 1 year of whole trial | 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHongqi Zhang, Ph.D
Xuanwu Hospital, Beijing
Outcome results
None listed