Safety and Efficacy Study of Iliac Bifurcation Stent Graft System, A Prospective, Multi-centre, Single-Arm Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 8
- 主要终点
- Patency rate of internal iliac artery
研究概览
简要总结
A prospective, multi-centre, single-arm clinical trial to evaluate the safety and efficacy of Iliac Bifurcation Stent Graft System.
详细描述
A prospective, multi-center, Single-Arm clinical trial to evaluate the safety and efficacy of endovascular treatment of the aortoiliac aneurysm or the iliac aneurysm by using Iliac Bifurcation Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. According to the requirements of the study, 64 patients preoperatively diagnosed with the aortoiliac aneurysm or the iliac aneurysm will be recruited and be treated by Iliac Bifurcation Stent Graft System under the guidance of aortic aortography. The safety of operations, stability of releasing stent and the accuracy of positioning will be evaluated intraoperatively. The safety and efficacy of aortic endovascular treatment of Iliac Bifurcation Stent Graft System will be observed by postoperative follow up scheduled 30 days and 180 days after the operation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years of age.
- •The subject or its legal representative sign the informed consent.
- •Patients with the aortoiliac aneurysm or the iliac aneurysm and need to endovascular restructure the internal iliac artery.
- •The anatomical structure of the iliac artery meets the following requirements:
- •The length of the anchoring zone of the external iliac artery is ≥15mm.
- •The diameter of the anchoring zone of the external iliac artery is between 7mm and 12mm.
- •The diameter of the external iliac artery is between 6mm-10mm.
- •The length of the anchoring zone of the internal iliac artery is ≥10mm.
- •Life expectancy is longer than one year.
排除标准
- •The patient is under 18 years old.
- •Pregnant or lactating woman.
- •The patient had a myocardial infarction or stroke within 3 months.
- •The patient had connective tissue disease, infectious aneurysm, and other active infections.
- •The patient has abdominal aortic aneurysm rupture.
- •The patient has a severe coagulation disorder.
- •Allergic to the material of stent or contrast media.
- •Patient's vascular morphology is not suitable for endovascular repairs, such as serious stricture, dilate, bend, sclerosis, etc. of the iliac artery.
- •Patients with severe mural thrombus in the aneurysm cavity, which may affect the implantation of Branch Stent.
研究组 & 干预措施
Intervention arm
Participants will be treated with Iliac Bifurcation Stent Graft System
干预措施: Iliac Bifurcation Stent Graft System (Device)
结局指标
主要结局
Patency rate of internal iliac artery
时间窗: 180days postoperative
Patency rate of internal iliac artery \>＝89%
次要结局
- Clinical success rate(30 days and 180days postoperative.)
- Device related mortality(Before discharge, 30 days and 180days postoperative.)
- Secondary interventional surgery(Before discharge, 30 days and 180days postoperative.)
- The incidence of major Adverse Device Effects (ADEs)(Before discharge, 30 days and 180 days postoperative。)
- Technical success rate(immediate)