"Percutaneous Axillary Access in the Endovascular Treatment of Thoracoabdominal Aortic Pathology"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Use of upper extremity access in endovascular repair of thoracoabdominal aortic aneurysms
研究概览
简要总结
Since the development of custom-made fenestrated and branched endografts a novel therapeutic option for the management of thoracoabdominal and para-renal aortic aneurysms was made accessible. Because of the design of these branched endografts, an arterial vascular access from the upper limb is required to allow selective catheterization of the branch component and the respective target vessel (celiac trunk, superior mesenteric artery, renal artery).2
详细描述
Primary end-point is to evaluate the requirement of upper extremity arterial access (UEA) retrospectively in the cohort of patients with thoracoabdominal aortic aneurysms treated by means fenestrated and/or branched endografts in Vascular surgery San Raffaele Hospital between 2013 and 2017, and prospectively in the next 50 patients that will be treated between 2017 and 2020.
Secondary end-point is an anatomical evaluation of the different sites available for UEA(upper extremity arterial access ) based on pre-operative imaging studies.
Materials and methods:
The investigators review a prospectively compiled Microsoft Office Excel database with the procedural details of the 34 patients treated at Vascular surgery of San Raffaele Hospital between October 2013 and March 2017 by means of total endovascular thoracoabdominal aortic aneurysm repair and of those of the next 50 patients who will be treated until December 2020. All patients in which an UAE (upper extremity arterial access ) is employed will be identified together with the side (left/right) and site (proximal/distal axillary artery, brachial artery) of vascular access. Furthermore, the pre-operative contrast-enhanced computed tomography scans (CTA) of all patients, stored in the hospital PACS, will be analyzed on the dedicated workstation with OsiriX software (Pixmeo sarl, Bernex, Switzerland) currently employed at Vascular surgery of San Raffaele Hospital for imaging assessment.
Requirement of an UEA(upper extremity arterial access ) during the procedure is extrapolated from the corresponding field of the available database and reported together with side and site of access and reason for the employment of UEA (upper extremity arterial access ) and for its location.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Use of upper extremity access in endovascular repair of thoracoabdominal aortic aneurysms
时间窗: between 2013 and 2020
* Endovascular graft design : branched / fenestrated * Employment of UEA(upper extremity arterial access ) during TAAA endovascular repair: yes / no * Side of UEA(upper extremity arterial access ) cannulation (left / right) * Site of UEA(upper extremity arterial access ) cannulation:proximal axillary artery / distal axillary artery / upper brachial artery. * Size of percutaneuos access sheath employed measured in French - Fr * Number of percutaneuos access vessel closure devices employed * Access closure specific outcome: primary success / secondary success / failure As reported on patients' charts and operative report
次要结局
- Upper extremity access vascular anatomy(between 2013 and 2017.)
研究者
Bertoglio Luca
Principal Investigator
IRCCS San Raffaele