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



Status:Enrolling by invitation
Conditions:Cardiology, Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 90
Updated:7/14/2018
Start Date:September 13, 2011
End Date:April 1, 2019

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3D Interventional Tools for Endovascular Procedures in the 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.

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.

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
We found this trial at
1
site
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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