跳至主要内容
临床试验/NCT01480206
NCT01480206已完成不适用

3D Interventional Tools for Endovascular Procedures in the OR

Philips Clinical & Medical Affairs Global1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2011年9月13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
58
试验地点
1
主要终点
feedback to improve the usability of the Vessel Navigator

研究概览

简要总结

As endovascular procedures become more complex, there is a growing need for 3D image overlay to assist with device guidance and placement. Currently, a 3D image is typically created intra-operatively using 3D rotational angiography (3D-RA) or cone-beam CT (XperCT). This 3D image may then be overlaid on live fluoroscopy to provide 3D guidance information (Dynamic 3D Roadmapping). Philips Healthcare multimodality overlay products allows registration of a pre-acquired MR/CT or 3D rotational image to live fluoroscopy.

详细描述

Endovascular treatment is performed under the guidance of an X-ray angiography system. Fluoroscopy and conventional 2D digital subtraction angiography (DSA) are used to navigate the interventional device (and implant) across the lesion to achieve a correct bridging of the diseased region of the vessel, while excluding the involvement of patent vessels. Drawbacks of these peripheral interventions include the radiation dose, use of contrast, and need for a clinician with excellent wire-handling skills. The use of 2D imaging alone may not be enough to describe the three-dimensional(3D) relationship between interventional devices (and implants) and the complex vascular anatomy, often making positioning, deployment and evaluation suboptimal. In addition, the endovascular approach can lead to complications such as in-stent thrombosis and type II endoleak (in the case of aortic aneurysms) for which 2D imaging along is again sub-optimal for re-intervention planning and guidance.

As endovascular procedures become more complex, there is a growing need for 3D image overlay to assist with device guidance and placement. Currently, a 3D image is typically created intra-operatively using 3D rotational angiography (3D-RA) or cone-beam CT (XperCT). This 3D image may then be overlaid on live fluoroscopy to provide 3D guidance information (Dynamic 3D Roadmapping). 3D navigation can also be acquired by registration of a pre-acquired MR/CT or 3D rotational image to live fluoroscopy.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with age 18-90, of both genders and all races
  • Patients undergoing elective AAA or TAA repair or carotid stenting or peripheral intervention
  • Patients already selected for endovascular treatment by preoperative CT angiogram
  • Patients with preoperative CT performed within 4 months of operation

排除标准

  • Patients refusing or incapable of providing informed consent
  • Patients undergoing emergent or ruptured AAA repair
  • Patients with known connective tissue disorders
  • Patients with aortic dissections
  • Patients participating in other EVAR, IDE, or IND trials
  • Patients with anticipated adjunctive intervention requiring additional intravenous contrast
  • Patients with anticipated endograft extension distal to the common iliac artery
  • Patients without CT angiogram performed at BIDMC with standard EVAR protocol
  • Patients without CT angiogram performed within 4 months of operation
  • Patients with glomerular filtration rate (GFR) < 60 mL/min/1.73m2
  • Patients with contraindication to intravenous contrast
  • Patients with disability or previous implants precluding adequate visualization on rotational imaging

结局指标

主要结局

feedback to improve the usability of the Vessel Navigator

时间窗: one month after procedure

PI answers questions to help improve the usability of the VesselNavigator

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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