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

Carotid Stenosis Clinical Trial

Official title:

3D Interventional Tools for Endovascular Procedures in the OR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480206
• Other study ID #: XCY611-110165
• Status: Completed
• Start date: September 13, 2011
• Est. completion date: August 1, 2021

Study information

• Verified date: March 2022
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm (AAA)
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Aneurysm, Thoracic
• Carotid Stenosis
• Thoracic Aortic Aneurysm (TAA)
• Visceral Artery Aneurysm

Intervention

Other:
• Endovascular Aortic Repair (EVAR)
Use of 3D interventional imaging tools in endovascular procedures in the surgical environment

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feedback to improve the usability of the Vessel Navigator	PI answers questions to help improve the usability of the VesselNavigator	one month after procedure