Comparison Between Open and Endovascular Surgical Techniques to Manage Vascular Injuries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 5-year treatment success rate
研究概览
简要总结
Traumatic injuries of peripheral arteries are often associated with multiple injuries, massive hemorrhage, state of shock, and loss of blood supply, as well as with high mortality. Traditionally, an open surgical approach is suggested for the management of artery injury. With the advancement of endovascular techniques, the traditional open vascular exposure and vessel repair are no longer the only option available. The purpose of this study is to compare the effectiveness, long-term safety and explore the safety and efficacy factors between open and endovascular surgical techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Injuries in the peripheral arteries; Loss of blood supply to the remote area; High-risk emergency artery reconstruction; Participate in the study voluntarily, accept follow up study. -
排除标准
- •Bleeding can be easily control; There is contraindications for surgical operation. -
研究组 & 干预措施
Endovascular treatment
干预措施: Endovascular treatment (Procedure)
Open surgery
干预措施: Open surgery (Procedure)
结局指标
主要结局
5-year treatment success rate
时间窗: 60 months
Treatment success is defined as restored blood flow without clinical complications.
次要结局
- Technically success rate of surgery(immediately after surgery)
- Surgery-related complications or death(60 months)
- Target lesion was treated by interventional or surgical therapy once again(60 months)
- Currence of stenosis of target lesion(60 months)
- Device-related serious adverse events(60 months)
研究者
Li Min
Vice Director
Jinan Military General Hospital