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

Official title

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.

Overview

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

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.

Interventions

• 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.
• 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)

Primary outcome measures

• 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. [Time frame: 18 month]

Secondary outcome measures (9)

• X-ray dose per procedure [Time frame: day 0]
• X-ray dose per procedure for the physician [Time frame: day 0]
• Contrast dose per procedure [Time frame: day 0]
• Length of ITU/HDU admission [Time frame: 18 months]
• Technical success [Time frame: day 0]
• Clinical success [Time frame: 1 month]
• 30-day mortality [Time frame: 30 days]
• Quality of life questionnaire [Time frame: 30 days]
• cost-effectiveness [Time frame: 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 7 centers

• Rinckenbach — Besançon
• NASR — Brest
• El Batti — Créteil
• Spear — Grenoble
• Pr Blandine Maurel — Nantes
• Jean-Baptiste — Nice
• Duprey — Reims

Identifiers

NCT: NCT06590532 · RC22_0396

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗