Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice (RADIOPROTEC)

French Randomised Controlled Trial Investigating the Clinical and Cost-effectiveness Role of a Cloud-based, Artificial Intelligent Image Fusion System to Guide Endovascular Aortic Aneurysm Repair and Aorto Iliac Revascularisation.

Evaluation of the clinical and cost-effectiveness of a mobile hybrid room compared with current practice without mobile hybrid room and imaging fusion guidance, in a French multicentre clinical setting.

The hypothesis is that the use of a mobile hybrid room with an automated artificial intelligent image fusion system would directly benefit patients, health worker and health care system by reducing procedure time, patient and staff exposure to radiation, improve clinical success and reduce costs (requested by a fixed imaging system installation and increasing the number of patients). This will also improve the safety of these procedures for patient and staff, when a conventional hybrid room is not available

Study Overview

• Status: Recruiting
• Conditions: Endovascular
• Intervention / Treatment: Procedure: Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV; Procedure: Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV

Detailed Description

Multi-centre, patient- and observer-blinded, two-armed, parallel groups randomised controlled trial. 7 French University hospital will include 350 patients presenting with AAA or aorto iliac occlusive disease suitable for endovascular treatment, to either repair using standard X-ray fluoroscopy imaging alone (the current reference standard) or augmented with automated image fusion. The study will be conducted in real-world clinical settings and will focus on multiple providers to demonstrate the effect in the wider healthcare system.

The trial will be conducted in 7 centres in France over 24 months. 350 patients will be recruited over a 18 month period, with 3 months minimum follow-up. Every vascular surgeon will be trained to use properly the fusion system, and the first 5 patients of each center won't be included.

Radiation parameters (machine report, passive dosimeters), iodinated contrast, technical and clinical success at 30-d and 3 months, procedure time, fluoro time, and costs will be collected.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Blandine Maurel, Pr; Phone Number: 02 40 16 53 72; Email: blandine.maurel@chu-nantes.fr

Study Locations

• France
  • Besançon, France, 25000
    • Not yet recruiting
    • Rinckenbach
    • Contact: Simon Rinckenbach, Pr; Phone Number: 03 81 66 80 99; Email: srinckenbach@chu-besancon.fr
    • Contact: Simon Rinckenbach, Pr
  • Brest, France, 29200
    • Not yet recruiting
    • NASR
    • Contact: Bahaa Nasr, Pr; Phone Number: 02 98 22 33 33; Email: nasr.bahaa@gmail.com
    • Contact: Bahaa Nasr, Pr
  • Créteil, France, 94000
    • Not yet recruiting
    • El Batti
    • Contact: Salma El Batti, Pr; Phone Number: 01 56 09 57 00; Email: salma.elbatti@aphp.fr
    • Contact: Salma El Batti, Pr
  • Grenoble, France, 38000
    • Not yet recruiting
    • Spear
    • Contact: Rafaëlle Spear, Pr; Phone Number: 04 76 76 50 26; Email: rafaelle.spear@gmail.com
    • Contact: Rafaëlle Spear, Pr
  • Nantes, France, 44000
    • Recruiting
    • Pr Blandine Maurel
    • Contact: Blandine Maurel, Pr; Phone Number: 0240165372; Email: blandine.maurel@chu-nantes.fr
    • Contact: Blandine MAUREL, Pr
  • Nice, France, 06000
    • Not yet recruiting
    • Jean-Baptiste
    • Contact: Elixène Jean-Baptiste, Pr; Phone Number: 04 92 03 38 35; Email: jean-baptiste.e@chu-nice.fr
    • Contact: Elixène Jean-Baptiste, Pr
  • Reims, France, 51100
    • Not yet recruiting
    • Duprey
    • Contact: Ambroise Duprey, Pr; Phone Number: 03 26 78 78 78; Email: ambroise.duprey@gmail.com
    • Contact: Ambroise Duprey, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Procedure carried out in an operating theatre equipped with a mobile operating theatre C-arm or a mobile planar or an old-generation fixed room with no image fusion available
• Surgeon trained in the use of image fusion
• Operator who has given their consent
• Endovascular management of an aorto-iliac artery disease or a sub-renal AAA using a sub-renal bifurcated stent graft
• Patient in possession of an angioscan less than 6 months old
• Patient of legal age who has given his/her consent
• Ionising radiation generator with up-to-date and validated quality control
• Participant affiliated to a Social Security scheme

Exclusion Criteria:

• First procedure with fusion for the previously trained surgeon.
• Procedure performed without an operating aid.
• Emergency procedure.
• Associated surgical procedure (femoropopliteal lesions, lesions of the renal or digestive arteries, iliac branch).

digestive arteries, iliac branch).

• Patients with AAA that cannot be treated by a simple sub-renal endovascular approach simple endovascular approach (subrenal bifurcated stent graft)
• Aortic emergencies (ruptured AAA).
• Persons under guardianship, curatorship or safeguard of justice
• Pregnant or breast-feeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fusion group; patient undergoing endovascular aortic repair with fusion imaging system guidance	Procedure: Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV; Cydar-EV image fusion is a CE-marked medical device, which instead of a table-tacked overlay uses computer vision to fuse pre-procedural 3D images with intra-operative 2D fluoroscopy automatically and in real-time.
Active Comparator: Control group; patient undergoing endovascular aortic repair without fusion imaging system guidance (only with X-rays and roadmaping)	Procedure: Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV; patients will be assigned either to an endovascular repair using standard X-ray fluoroscopy imaging alone (the current reference standard)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost consequence analysis associated with endovascular procedures performed using automatic imaging fusion guidance and conventional endovascular technique performed without image fusion guidance up to 30 days time horizon and a collective perspective.	To compare the costs and consequences associated with endovascular procedures performed using automatic imaging fusion guidance and conventional endovascular technique performed without image fusion guidance. Consequences are listed in the secondary endpoints. Cos twill be express in €.	18 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality	30-day mortality	30 days
X-ray dose per procedure	exposure parameters from the machine	day 0
X-ray dose per procedure for the physician	exposure parameters from the dosimeter	day 0
Contrast dose per procedure	Contrast dose used	day 0
Length of ITU/HDU admission	Length of ITU/HDU admission	18 months
Technical success	defined as proximal and distal seal zone at least 10mm and no evidence of endoleak or revascularization success.	day 0
Clinical success	defined as primary patency rate or endovascular exclusion of the aneurysm	1 month
Quality of life questionnaire	EQ-5D-5L assessement	30 days
cost-effectiveness	Net financial impact over 5 years of SHMA deployment (based on the 5-year projection and different different scenarios for the spread of the technology)	5 years

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: September 6, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RC22_0396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No