A Multicenter Prospective Study of New Flow Diverter Stent on the Treatment of Intracranial Aneurysms in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Aneurysm Complete Occlusion Rate
研究概览
简要总结
Intracranial aneurysm, as a common cerebrovascular disease, has a variety of treatment methods, including surgical treatment and endovascular treatment. Among these treatment methods, flow diverters have attracted much attention due to their unique therapeutic principles. Flow diverters help promote thrombus formation within the aneurysm by altering the direction and dynamics of blood flow, thereby achieving the purpose of treatment. 1-5 Flow diverters such as the Pipeline™ device have been proven to be safe and effective for the treatment of intracranial aneurysms and have gradually been recognized as the preferred device for the management of intracranial aneurysms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form and agreement to comply with protocol requirements.
- •Age 22 to 80 years.
- •Diagnosed with intracranial wide-neck aneurysm and planned for treatment with a flow diverter stent.
- •Parent artery distal/proximal diameter compatible with available sizes and models of flow diverter stents, and treatment to be performed in accordance with the China NMPA-approved indications and instructions for use.
排除标准
- •Need for treatment of another aneurysm in the affected territory of the target aneurysm using a different therapeutic modality during the study period.
- •Prior intracranial implant (e.g., coils) in the target intracranial aneurysm territory within 6 months before enrollment.
- •Prior surgery, including endovascular treatment, within 30 days before enrollment.
- •Modified Rankin Scale (mRS) score ≥
- •Any known contraindication to flow diverter stent treatment or antiplatelet therapy, including contraindications to dual antiplatelet therapy (DAPT).
- •Pre-existing stent/flow diverter placed in the parent artery of the target aneurysm location.
- •Investigator judges that the patient's health or the validity of study results (e.g., high risk of neurological events, conditions that may increase the chance of stroke) could be compromised by study participation.
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- •Known allergy to platinum or cobalt-chromium alloys (including major elements: platinum, cobalt, chromium, nickel, or molybdenum).
研究组 & 干预措施
Flow Diverter Stent Treatment Group
干预措施: Novel Flow Diverter Stent (Device)
结局指标
主要结局
Aneurysm Complete Occlusion Rate
时间窗: 1 year post-procedure
Proportion of patients with complete occlusion of the target aneurysm at 1 year post-procedure, as assessed by the core imaging laboratory using the Raymond-Roy Occlusion Classification (Class I: complete obliteration).
次要结局
未报告次要终点