Left Subclavian Artery Reconstruction With Laser-assisted Fenestration During the Procedure of Thoracic EndoVascular Aortic Repair for Type B Aortic Dissection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Freedom From All-cause Reintervention, All-cause Mortality and Major Adverse Events Within 30 Days After Procedure
研究概览
简要总结
This study aims to evaluate the feasibility, effectiveness, and safety of in-situ laser-assisted fenestration on the left subclavian artery during the procedure of thoracic artery endovascular repair
详细描述
This study is a single-arm, prospective study. All patients with type B aortic dissection (TBAD) present with the proximal tear site located approximately close to the left subclavian artery and a reconstruction of the left subclavian artery is necessary are included in the present study. During the procedure of thoracic artery endovascular repair (TEVAR), the left subclavian artery will be reconstructed with laser-assisted fenestration and the fenestrated stent will be covered stents (fluency, viabhan, lifestream).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female over 18 years of age;
- •Type B Aortic Dissection;
- •The left subclavian artery should be reconstructed during the TEVAR procedure.
- •Patient is willing to provide informed consent and comply with the required follow up visits, testing schedule and medication regimen;
排除标准
- •Life expectancy of < 5 years;
- •Patients need open surgery repair for the aortic diseases.
研究组 & 干预措施
Patients with TBAD treated with TEVAR
In situ laser assisted fenestration for the left subclavian artery during the TEVAR procedure for TBAD.
干预措施: In situ laser assisted fenestration (Procedure)
结局指标
主要结局
Freedom From All-cause Reintervention, All-cause Mortality and Major Adverse Events Within 30 Days After Procedure
时间窗: within 30 days after procedure
The primary safety endpoint was freedom from major adverse events within 30 days after procedure. The major adverse events included mortality, stroke, myocardial infarction, rupture, paraplegia, type Ia endoleak, major bleeding, acute kidney injury, limb ischemia, bowel ischemia, retrograde dissection, stent-induced new entry (SINE), access site complications and unplanned reinterventions.
次要结局
- Aortic Disease Related Mortality(12 months)
- Incidence of Endoleak Within 12 Months After Procedure(12 months)
- Technical Success Rate During the Procedure(During the procedure)
- Patency Rate of Branches Stents 12 Months After Procedure(12 months)
研究者
Kaichuang Ye, MD, PhD
Department of Vascular Surgery
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University