Skip to main content
OpenTrials
Completed

NCT Number: NCT01480206

Overlay of 3D Scans on Live Fluoroscopy for Endovascular Procedures in the Hybrid OR

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Endovascular Aortic Repair (EVAR)

Other

Use of 3D interventional imaging tools in endovascular procedures in the surgical environment

Other names: EVAR, TEVAR

Primary outcomes

  1. feedback to improve the usability of the Vessel Navigator

    Time frame: one month after procedure

    PI answers questions to help improve the usability of the VesselNavigator

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Official study title

3D Interventional Tools for Endovascular Procedures in the OR

Important dates

Study start
2011
Primary completion
2021
Study completion
2021
First posted
Nov 28, 2011
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.