Superiority Trial of Type b Aortic Dissection Treatment Combined With Implantation of Bare Metal Stent in Abdominal Part of Aorta Versus Conventional Type b Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 主要终点
- Permanent neurological events
研究概览
简要总结
Authors hypothesize that thoracoabdominal aortic repair combined with bare metal stent implantation is superior over standard thoracoabdominal aortic repair.
详细描述
Main hypothesis of this study is that thoracoabdominal aortic repair combined with bare metal stent implantation is better permanent neurological deficits, perioperative bleeding, malperfusion of viscera over conventional thoracoabdominal aortic repair.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic aortic dissection type B
- •Aortic size in descending thoracoabdominal aorta (TAA) > 55 mm
排除标准
- •concomitant cardiac pathology
- •concomitant oncology diseases in the last 5 years
- •acute aortic dissection
- •aortic size in visceral zone >45 mm
- •connectivity tissue diseases
研究组 & 干预措施
Hybrid TAAD repair
The group includes patients who underwent open thoracoabdominal aortic repair + abdominal stenting.
干预措施: Open thoracoabdominal aortic repair + abdominal stenting (Procedure)
Conventional TAAD repair
The group includes patients who underwent classic thoracoabdominal aortic repair with dacron prosthesis.
干预措施: Classic thoracoabdominal aortic repair (Procedure)
结局指标
主要结局
Permanent neurological events
时间窗: 30 days
Quantity of permanent neurological events such as stroke and paraplegia by 30th day after procedure.
次要结局
- Mortality(6 months)
- Visceral malperfusion(6 months)
- Perioperative bleeding(5 days after procedure)
研究者
Dmitry Sirota
Cardiac surgeon
Meshalkin Research Institute of Pathology of Circulation