Condition category
Circulatory System
Date applied
30/10/2017
Date assigned
08/11/2017
Last edited
10/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Imaging systems have evolved to facilitate aortic aneuryms endovascular repairs (EVAR) (a surgery to repair a widened area in the large artery that carries from the heart to the stomach, pelvis and legs). The latest hybrid rooms have advanced imaging applications, such as contrast enhanced Cone Beam Computed Tomography (ceCBCT, 3D images acquired through a C-arm rotation around the patient), and pre-operative Computed Tomography Angiography (CTA) images fusion with live fluoroscopy (continuous x-ray imaging) to provide a “3D roadmap”. This helps navigate through the aorta navigation and increases accuracy of endograft implantation (a tube covered in mesh placed in the aorta to help blood pulse through it). Despite the current widespread of these new imaging applications, little has been published on their impact on radiation exposure. Radiation effects are cumulative and put patients at risk of radiation injuries after exposure. However, clinical staff regularly exposed to radiation during everyday fluoroscopy-directed procedures is exposed to an increased incidence of stochastic injuries (chance or random injuries). Published evidence suggests that repeated injections of contrast media contribute to the development of lifelong nephropathy (kidney disease or damage). It has been demonstrated in a study conducted in a single center EVAR performed under fusion guidance in a hybrid room following the ALARA (as low as reasonably achievable) principles allowed significant reduction of radiation exposure and contrast media volume. The aim of this study is to evaluate if such dose and contrast volume reduction can also be observed in a study with more than one centres.

Who can participate?
Adults aged 18 to 99 years old who are undergoing EVAR with a bifurcated endograft in the hybrid room with fusion imaging guidance.

What does the study involve?
Aortic centers record data for all consecutive patients undergoing endovascular aneurysm repair (EVAR) with a bifurcated endograft. All centers followed the As Low As Reasonable Achievable (ALARA) principles during EVAR. The same dose protocol was used in every center (for both fluoroscopy and angiography). Radiation doses are evaluated through two validated parameters: The Dose-Area product and the Cumulative Air-Kerma that are provided by the imaging systems. All systems internal dosimeters calibration are checked by the hybrid room manufacturer prior to patient inclusion.

What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating.

Where is the study run from?
1. Heart of England NHS Foundation Trust (UK)
2. Aortic Center, Institut Coeur-Poumon (France)
3. Royal Oldham Hospital (UK)
4. Maimonides Medical Center (USA)
5. CHU Rangueil (France)
6. Takai Hospital (Japan)

When is the study starting and how long is it expected to run for?
October 2015 to October 2017

Who is funding the study?
Lille University Aortic Centre (France)

Who is the main contact?
Professor Stephan Haulon

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephan Haulon

ORCID ID

http://orcid.org/0000-0003-4560-680X

Contact details

Aortic Center
CHRU Lille – Hôpital Cardiologique
1
Blvd du Pr Jules Leclercq
Lille
59037
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

REVAR2017

Study information

Scientific title

Fusion Imaging-Guided EVAR Reduces Radiation - Results from a prospective multicentric study

Acronym

REVAR

Study hypothesis

Use of fusion imaging (between fluoroscopy and preoperative angioCT-scan) and strong appliance to the radiation protection principles in a modern hybrid room seemed to be associated with a radiation dose reduction during aortic endovascular repair in a previously published monocentric study (DOI: 10.1016/j.ejvs.2014.05.026).
The purpose of this study is to evaluate if similar results could also be observed in a multicentric study.

Ethics approval

CERAR Ethical Committee of the French Aesthesiologist Society, 20/02/2016, ref: IRB 00010254-­2015‐023

Study design

Prospective multicentre observational multicentric study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Radiation effects

Intervention

This study is a prospective multicentric observational study. Six high volume aortic centers record data for all consecutive patients undergoing endovascular aneurysm repair (EVAR) with a bifurcated endograft.

All centers followed the As Low As Reasonable Achievable (ALARA) principles during EVAR. The same dose protocol is used in every center (for both fluoroscopy and angiography). Every case is performed using 2d/3d fusion with aortic volume rendering generated from the preoperative high resolution computed tomography angiography (CTA). Accuracy of the registration is adjusted with dynamic registration if required. Completion angiography, to assess technical success at the end of each procedure, is performed with a standard 2-dimension (2D) short angiography. All procedures are carried out by experienced operators under general or locoregional anesthesia.

Radiation doses are evaluated through two validated parameters in the literature: The Dose-Area product (DAP, in Gy.cm²) and the Cumulative Air-Kerma (CAK, in mGy), that were provided by the imaging systems. All systems internal dosimeters calibration are checked by the hybrid room manufacturer prior to patient inclusion.

Written consent is obtained for all patients prior to enrollment.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Dose-Area Product (DAP, in Gy.cm²) is measured using the internal dosimeter of the imaging equipment at the end of each procedure.

Secondary outcome measures

1. Cumulative Air-Kerma (CAK, in mGy) is measured using the internal dosimeter of the imaging equipment at the end of each procedure
2. Fluoroscopy Time (FT, min) is measured using the imaging equipment at the end of each procedure.
3. Duration of fusion imaging preparation (defined as time spent on the workstation from the start of the aorta analysis protocol to the launch of the fusion software) measured using a chronometer and reported by the investigators at the beginning of each procedure.
4. Duration of fusion imaging registration (time spent from the start of the bone registration to the switch from the bone mask to the vascular mask) measured using a chronometer and reported by the investigators at the beginning of each procedure.
5. Total Contrast Media Volume (cc) is measured manually by reporting the total volume of contrast medium injected to the patient during the case at the end of each procedure

Overall trial start date

01/10/2015

Overall trial end date

31/10/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. All consecutive patients undergoing endovascular aneurysm repair (EVAR) with a bifurcated endograft in the hybrid room with fusion imaging guidance
2. Aged 18 to 99 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Patients treated in emergency
2. Patients with planned additionnal procedures (hypogastric embolization or iliac branch for the graft for example)
3. Patients refusing enrollment
4. Patients under the age of 18 yo or not able to give their consent

Recruitment start date

01/02/2016

Recruitment end date

30/11/2016

Locations

Countries of recruitment

France, Japan, United Kingdom, United States of America

Trial participating centre

Institut Coeur-Poumon
Aortic Center
Lille
59000
France

Trial participating centre

Heart of England NHS Foundation Trust
Birmingham
B9 5SS
United Kingdom

Trial participating centre

Royal Oldham Hospital
Manchester
OL1 2JH
United Kingdom

Trial participating centre

Maimonides Medical Center
New York
NY 11219
United States of America

Trial participating centre

CHU Rangueil
Toulouse
31400
France

Trial participating centre

Takai Hospital
Toki
509-5301
Japan

Sponsor information

Organisation

Vascular Surgery Department

Sponsor details

CHRU Lille – Hôpital Cardiologique
1
Blvd du Pr Jules Leclercq
Lille
59037
France

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Lille University Aortic Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The authors consider submission to the Annals of Surgery Journal by the 31/12/2017. Both study protocol and statistical analysis plan can be shared if requested.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from S. Haulon, Aortic Centre, Department of Aortic and Vascular Surgery, Hôpital Marie Lannelongue, Le Plessis-Robinson, INSERM UMR_S 999, Univerité Paris Sud, France (email: s.haulon@ccml.fr)

Intention to publish date

31/12/2017

Participant level data

Available on request

Basic results (scientific)

Publication list

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29895398

Publication citations

Additional files

Editorial Notes

10/07/2018: Publication reference added.