A Study on the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The Incidence of Major Adverse Events (MAE) within 30 Days postoperatively.
研究概览
简要总结
The objective of this study is to evaluate the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms(CIAA).
详细描述
The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients who have undergone implantation of the iliac bifurcation stent graft system;
- •Patients with complete medical records
排除标准
- •Patients with ruptured aortic aneurysm;
- •Patients with infected or mycotic aortic aneurysm;
- •Patients with connective tissue diseases, such as systemic lupus erythematosus, Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease
结局指标
主要结局
The Incidence of Major Adverse Events (MAE) within 30 Days postoperatively.
时间窗: within 30 Days postoperatively
Major Adverse Events (MAE) are defined as follows: all-cause mortality related to iliac artery aneurysms associated with the surgery or device, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, and intestinal ischemia.
he patency rate of internal iliac artery (IIA) at 12 months postoperatively
时间窗: at 12 months postoperatively
The patency rate of internal iliac artery (IIA) defined as blood flow without occlusion maintained through the device without intervention
次要结局
- The incidence of conversion to open surgery or secondary interventional procedures due to iliac artery aneurysms before discharge and at 12 months postoperatively.(before discharge and at 12 months postoperatively)
- Device-related adverse events before discharge and at 12 months postoperatively(before discharge and at 12 months postoperatively.)
- The incidence of malfunction before discharge and at 12 months postoperatively.(before discharge and at 12 months postoperatively.)
- Incidence rate of Type I/III endoleak caused by the iliac bifurcation system that necessitate reintervention before discharge and at 12 months postoperatively.(before discharge and at 12 months postoperatively.)
- The immediate technical success during intraoperative procedures.(during intraoperative procedures)