In Vivo Evaluation of Image Registration Techniques During Endovascular Repair

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

In Vivo Evaluation of Image Registration Techniques During Endovascular Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116880
• Other study ID #: 2016/533
• Status: Completed
• Start date: April 19, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: September 2018
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Fluoroscopy is traditionally used for guidance of endovascular aortic repair (EVAR). In order to minimize exposure to radiation and nephrotoxic contrast medium, it is possible to generate a navigation road map by registering the intraoperative images with preoperative computed tomography angiograph (CTA). In modern hybrid operating rooms, several commercial solutions for this exists today (e.g. Siemens Syngo iPilot, Phillips Vesselnavigator). In order to register (fuse) the preoperative and intraoperative imaging to each other, a registration algorithm has to be applied. Sufficient accuracy of this algorithm is crucial, for if it fails the road map cannot be used for intraoperative navigation. The purpose of this study is therefore to evaluate two different 3D registration algorithms with regard to registration accuracy.

Description:

Two different registration algorithms will be tested:

1. registration algorithm - centerline registration algorithm (Sintef, Trondheim) A catheter equipped with a position sensor records the travelled path of the instrument, which is assumed to be close to the centerline of the aorta. From the preoperative computer tomography scan (CT) the aorta is segmented and vessel centerline is extracted. The centerline from the position sensor recordings is registered to the extracted centerline of the preoperative CT.

2. 3D-3D registration algorithm (Syngo iPilot, Siemens Medical Solutions, Munich). Intraoperative cone-beam-CT (CBCT) is registered to the preoperative CT

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• infrarenal or juxtarenal abdominal aortic aneurysm

• undergoing EVAR

• informed consent

Exclusion Criteria:

• under 18 years

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Procedure:
• Endovascular aortic repair
Endovascular aortic repair

Locations

Country	Name	City	State
Norway	St. Olavs hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Registration accuracy of registration algorithms	Measure the 3D spread between defined points (registration plate, bony landmarks at vertebrae, vessels if visable)	Immediately