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临床试验/NCT03993496
NCT03993496Unknown不适用

Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair

University of Ottawa1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年8月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Fractional aneurysm sac size reduction 1 year after surgery

研究概览

简要总结

Endovascular abdominal aortic aneurysm repair (EVAR) aims to reduce the risk of aneurysm (AAA) rupture by reducing the blood pressure transmitted to the wall of the aneurysm. Aneurysms that remain pressurized despite EVAR may continue to grow, therefore requiring additional surgical interventions. The purpose of this study is to infer the reduction of pressure transmitted to the aneurysm wall by using intraoperative ultrasound ('M-Mode') to assess the pulsatility of the aneurysm wall. The hypothesis is that intraoperative reduction in aneurysm wall pulsatility after EVAR will correlate with improved aneurysm sac size reduction.

详细描述

Endovascular abdominal aortic aneurysm repair (EVAR) aims to reduce the risk of aneurysm (AAA) rupture by reducing the blood pressure transmitted to the wall of the aneurysm. Unfortunately, this procedure is not always successful, and patients need to return to the operating room for further procedures because the aneurysm wall remains pressurized and the aneurysm continues to grow. Currently, there is no standard non-invasive way of measuring aneurysm pressure. The purpose of this study is to infer the reduction of pressure transmitted to the aneurysm wall by using intraoperative ultrasound ('M-Mode') to assess the pulsatility of the aneurysm wall. The hypothesis is that intraoperative reduction in aneurysm wall pulsatility after EVAR will correlate with improved aneurysm sac size reduction. This is clinically relevant because physiologic intraoperative feedback of aneurysm pressure may potentially influence surgical decision making in the future, reducing unnecessary re-interventions. This will also improve our understanding of the intraoperative physiologic response to EVAR.

Our primary research question is in patients receiving elective endovascular repair of abdominal aortic aneurysms (EVAR), does the change in intraoperative ultrasound estimated aneurysm wall pressure during EVAR correlate with aneurysm sac size reduction 1 year after surgery? Secondary objectives are to assess correlation between intraoperative ultrasound estimated aneurysm wall pressure and endovascular leaks and aneurysm-related re-interventions.

A prospective, observational, assessor-blinded and surgeon-blinded study will be conducted at the TOH Civic Campus in Ottawa, ON in order to satisfy the objectives of the study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Elective endovascular aneurysm repair (EVAR) surgery
  • Infrarenal abdominal aortic aneurysm
  • Age greater than 18 years old

排除标准

  • Prior abdominal aortic aneurysm procedures
  • Inability to visualize aneurysm on ultrasound
  • Inability to provide consent
  • Irregular arrhythmias

结局指标

主要结局

Fractional aneurysm sac size reduction 1 year after surgery

时间窗: 1 year

Aneurysm sac size reduction will be measured using surveillance ultrasound 1 year after surgery. Post-operative imaging reports will be accessed through the hospital electronic health records system (EPIC).

次要结局

  • Fractional aneurysm sac size reduction 30 days after surgery(30 days)
  • Endovascular leaks (Type 1, 2, 3, 4)(30 days)
  • Aneurysm-related re-interventions(1 year)

研究者

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

Mark Rockley

Co-Investigator

University of Ottawa

研究点 (1)

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