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临床试验/NCT03484013
NCT03484013已完成不适用

Totally Percutaneous Approach to Endovascular Treatment of Aortic Aneurysms (PEVAR-PRO)

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2019年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
320
试验地点
1
主要终点
technical success

研究概览

简要总结

Purpose of the study is the evaluation of the applicability of the percutaneous technique through double Proglide and Pre-Close Technique to the treatment of complex aortic aneurysms with thoracic endoprosthesis (TEVAR), fenestrated or branched (F / B-EVAR) in which patient-related factors, the devices used or the procedure, could affect the performance.

详细描述

Endovascular treatment using a percutaneous technique (Percutaneous Endovascular Aneurism Repair - P-EVAR) has been used with increasing frequency to treat aortic aneurysms by reducing operative times, postoperative pain and length of stay, compared to treatment by surgical femoral access. During EVAR procedures, two accesses to the femoral arteries are required to introduce the necessary tools for the stentgraft implantation. Such accesses can be classically obtained by surgical incision, isolation of the common femoral arteries and direct introduction of the devices.

Alternatively, the most modern approach involves direct puncture of the artery (without the need for incision), through the skin and closure of the arterial breach through prolonged manual compression of the vascular closure or systems (Vascular Closure Devices - VCD) specifically designed. Among the various closure devices one of the most used and studied is the Perclose Proglide (Abbott Vascular, Santa Clara CA, USA) that allows to affix a polypropylene stitch to close the arterial breach. When closing high-caliber accesses (> 8 French) it is necessary to use two devices that must be positioned before inserting the introducer ("Pre-Close Technique").

Few studies have so far evaluated the application of this method to the treatment of complex cases such as thoracic or thoracoabdominal aortic aneurysms that requiring the use of high caliber introducers.

The objective of the study is the evaluation of the technical success and clinical outcomes of the PEVAR technique with a double vascular suture device Perclose ProGlide (Abbott Illinois, U.S.A.).Endovascular treatment using a percutaneous technique (Percutaneous Endovascular Aneurism Repair - P-EVAR) has been used with increasing frequency to treat aortic aneurysms by reducing operative times, postoperative pain and length of stay, compared to treatment by surgical femoral access. During EVAR procedures, two accesses to the femoral arteries are required to introduce the necessary tools for the stentgraft implantation. Such accesses can be classically obtained by surgical incision, isolation of the common femoral arteries and direct introduction of the devices.

Alternatively, the most modern approach involves direct puncture of the artery (without the need for incision), through the skin and closure of the arterial breach through prolonged manual compression of the vascular closure or systems (Vascular Closure Devices - VCD) specifically designed. Among the various closure devices one of the most used and studied is the Perclose Proglide (Abbott Vascular, Santa Clara CA, USA) that allows to affix a polypropylene stitch to close the arterial breach. When closing high-caliber accesses (> 8 French) it is necessary to use two devices that must be positioned before inserting the introducer ("Pre-Close Technique").

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients aged ≥ 18 years, belonging to the Operative Unit of Vascular Surgery of the San Raffaele Hospital,
  • patients candidates for endovascular treatment for thoracic, thoracoabdominal or abdominal aortic pathologies.

排除标准

  • There are no criteria for exclusion of subjects from the study.

结局指标

主要结局

technical success

时间窗: during the surgery

Use of femoral artery access in endovascular repair of aortic aneurysm (time frame between 2015 and 2020) * Endovascular procedure: TEVAR - EVAR - B/FEVAR * Side of femoral access: right- left * Employment of downsizing on the femoral access: yes - no, as reported on patients' charts and operative report * Size of percutaneous access sheath employed measured in French - Fr * Number of percutaneous access vessel closure devices employed * Access closure specific outcome: success - failure, as reported on patients' charts and operative report * Cause of failure: hemorrhagic - occlusive, as reported on patients' charts and operative report

次要结局

  • minor complications(30 days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bertoglio Luca

Principal Investigator

IRCCS San Raffaele

研究点 (1)

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