In Vivo Evaluation of Image Registration Techniques During Endovascular Repair

NCT03116880 | Completed

• 1 other identifier: 2016/533
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Aneurysm, Abdominal

Keywords

Aorta, Abdominal/surgery; Endovascular Procedures

Outcome Measures

Primary Outcomes (1)

• Registration accuracy of registration algorithms

  Measure the 3D spread between defined points (registration plate, bony landmarks at vertebrae, vessels if visable)

  Immediately

Study Arms (1)

Image registration

Procedure: Endovascular aortic repair

Interventions

Endovascular aortic repair PROCEDURE

Endovascular aortic repair

Image registration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing endovascular aortic repair at St. Olav Hospital, Trondheim, Norway

You may qualify if:

• infrarenal or juxtarenal abdominal aortic aneurysm
• undergoing EVAR
• informed consent

You may not qualify if:

• under 18 years

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St. Olavs hospital

Trondheim, 7030, Norway

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Øystein Risa

  Norwegian University of Science and Technology, Department of Circulation and Medical Imaging

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 17, 2017
• Study Start: April 19, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

NO (1)