A Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Controlled Trial of Bioabsorbable/Nufairy Coil Embolization System for the Treatment of Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Successful occlusion rate of aneurysm at 12-month post-procedure.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years old and ≤80 years old at the time of signing the informed consent;
- •Intracranial aneurysm diagnosed by CTA, MRA, DSA neuroimaging examination;
- •Subjects whose target aneurysms are suitable for embolization with flow diverter or intracranial arterial stents assisted by coils, and the entire treatment can be performed in a single procedure;
- •The subjects or the subject's guardian signs the informed consent voluntarily and is willing to accept follow-up.
排除标准
- •mRS Score ≥3 points in clinical assessment prior to enrollment;
- •Subjects who received neurosurgical or endovascular treatment for recurrent aneurysms;
- •Subjects with multiple aneurysms;
- •Subjects with ruptured aneurysms <30 days;
- •Significant stenosis (≥50%) of parent artery;
- •Subjects who are not suitable for anesthesia or intravascular surgery, such as major diseases of the heart, lung, liver, spleen, kidney, brain tumors, severe active infections, disseminated intravascular coagulation, and a history of serious mental illness;
- •Subjects who have undergone major surgical procedures (such as internal fixation device implantation of limbs fracture, tumor resection, major organ surgery, etc.) within 30 days before signing the informed consent or plan to undergo major surgical procedures within 60 days after signing the informed consent;
- •Subjects with morphology or lesions that may interfere with device use, including but not limited to: carotid artery dissection, vasculitis, aortic dissection, limited vascular access (e.g., severe intracranial vessel tortuosity, severe intracranial vessel spasm that does not respond to medical treatment, other anatomical or clinical changes that impede device access;
- •Treatment contrainidations of coils, including but not limited to: contrainidations of digital subtraction angiography, allergy to or intolerance of contrast agents, allergy to or intolerance of anti-platelet and anticoagulant drugs required for treatment, platinum-tungsten alloy, and poly(co-glycolic acid) (PLGA);
- •Pregnant or lactating women;
- •Life expectancy is less than 18 months;
- •Subjects participating in other drug or device studies did not meet the endpoint.
结局指标
主要结局
Successful occlusion rate of aneurysm at 12-month post-procedure.
时间窗: 12 month
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).
次要结局
- Device-related serious adverse events at 1, 6, and 12 months after surgery;(12 month)
- Retreatment rate of aneurysm at 12-month post-procedure.(12 month)
- Complete occlusion rate of aneurysm at 12-month post-procedure.(12 month)
- Recurrence rate of aneurysm at 12-month post-procedure.(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)