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

• Sponsor: Philips Clinical & Medical Affairs Global (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01480206
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Actual Duration (Months): 118.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm (AAA); Thoracic Aortic Aneurysm (TAA); Carotid Stenosis; Visceral Artery Aneurysm	Other: Endovascular Aortic Repair (EVAR)

Detailed Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 58 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 3D Interventional Tools for Endovascular Procedures in the OR
• Actual Study Start Date: Sep 13, 2011
• Actual Primary Completion Date: Apr 1, 2021
• Actual Study Completion Date: Aug 1, 2021

Outcome Measures

Primary Outcome Measures

1. feedback to improve the usability of the Vessel Navigator [one month after procedure]

   PI answers questions to help improve the usability of the VesselNavigator

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Philips Clinical & Medical Affairs Global

Investigators

• Principal Investigator: Marc Schermerhorn, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philips Clinical & Medical Affairs Global
• ClinicalTrials.gov Identifier: NCT01480206
• Other Study ID Numbers: XCY611-110165
• First Posted: Nov 28, 2011
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Additional relevant MeSH terms: Carotid Stenosis; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic

Study Results

No Results Posted as of Mar 22, 2022