Outcomes of Secondary Endovascular Aortic Repair After Initial Aortic Cross Replacement by a Frozen Elephant Trunk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Absence of endoleak after secondary connexion
研究概览
简要总结
Objective Complex aortic pathology has been revolutionized with the use of hybrid prostheses such as the Thoraflex® Hybrid Frozen Elephant Trunk (FET). The aim of this study was to evaluate the midterm results of secondary extension of the FET by thoracic endovascular aortic repair (TEVAR). Few data are present in the literature regarding the outcomes of this secondary treatment.
The investigators perform a prospective study between 2015 and 2022 in a tertiary aortic center on all consecutive patients having undergone TEVAR after FET implantation. The TEVAR endograft covered most of the 10 cm FET module with 2 to 4 mm oversizing. All patients were monitored by computerized angiography (CTA) at 6-month and yearly thereafter.
The aim of this study was the feasibility of theses secondary connexion and the mid term outcomes of the endovascular treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with aortic cross replacement by FET and
- •Type 1 and Type 2 Thoracoabdominal aneurysm (TAAA) with a diameter at > 6 cm or
- •an aortic dissection, Type A (TAAD) or Type B (TBAD) with either organ malperfusion due to compression of the true channel or aneurysmal evolution of the dissected aorta, or
- •A defect in the expansion of the FET module
排除标准
- •No aortic cross replacement by FET
结局指标
主要结局
Absence of endoleak after secondary connexion
时间窗: yearly thereafter up to 5 years
Absence of Type 1A endoleak
次要结局
- Feasibility of the secondary connexion(During the surgery)
- Absence of endoleak after secondary connexion(early thereafter up to 5 years)
研究者
Aurélien Hostalrich
Hostalrich Aurelien, MD
University Paul Sabatier of Toulouse