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临床试验/NCT03875846
NCT03875846已完成不适用

Intraoperative Simultaneous Pressure Guided Revascularization Study

Mark Rockley1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Major Adverse Limb Event (MALE)

研究概览

简要总结

This study aims to determine whether intraoperative physiologic measurements of blood flow to the leg during endovascular treatment of Peripheral Arterial Disease (PAD) can predict future clinical outcomes.

详细描述

Lower extremity peripheral arterial disease (PAD) caused by atherosclerosis can cause cause leg pain, gangrene, and limb loss. PAD is a result of poor blood flow to the extremity, and the emerging most common initial method of interventional treatment is endovascular therapy, for example angioplasty or stenting. The poor blood flow to the extremity can be inferred by the hemodynamic pressure of blood in the leg. These toe or ankle pressure measurements are typically performed before surgery to diagnose PAD, and after surgery as surveillance.

However, endovascular treatment has a high failure rate often exceeding 20% within a year. There is evidence that physiologic measurements prior to treatment and after treatment are closely related to clinical outcomes. This study introduces these physiologic measurements to the operating room, to determine if physiologic improvement can be detected instantaneously during endovascular revascularization. Patients will be followed for a year following surgery to detect hemodynamic and clinical outcomes. The rationale of these intraoperative measurements would be to potentially guide future surgery, by providing real-time hemodynamic feedback to the operator.

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

  • Patients undergoing elective or semi-urgent endovascular procedures on lesions of the aorta, iliac, femoral, popliteal, or tibial arteries
  • Symptomatic, atherosclerotic Peripheral Vascular Disease. These symptoms include any Rutherford's classification.

排除标准

  • Concurrent hybrid open procedure during endovascular revascularization requiring vascular clamping for any period of time, such as endarterectomy
  • Prior open vascular surgery performed on the affected leg
  • Emergent intervention for Acute Limb Ischemia, defined as symptoms lasting less than 14 days
  • Non-femoral vascular access

结局指标

主要结局

Major Adverse Limb Event (MALE)

时间窗: 1 Year

Composite outcome of major amputation above the ankle, major re-intervention in the form of catheter-directed thrombolysis, open bypass or thrombectomy.

次要结局

  • Target Vessel Patency(1 Year)
  • Major Amputation(1 Year)
  • Minor Amputation(1 Year)
  • Post-Operative Hemodynamic Measurements(1 - 3 Months)
  • Improvement in Rutherford's Classification of Peripheral Vascular Disease(1 Year)
  • Target Vessel Re-Intervention(1 Year)

研究者

发起方
Mark Rockley
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mark Rockley

Study Coordinator

University of Ottawa

研究点 (1)

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