Clinical trial NCT06590532: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endovascular
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: 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.
timeFrame: 18 month
Secondary outcomes:
measure: X-ray dose per procedure
timeFrame: day 0
measure: X-ray dose per procedure for the physician
timeFrame: day 0
measure: Contrast dose per procedure
timeFrame: day 0
measure: Length of ITU/HDU admission
timeFrame: 18 months
measure: Technical success
timeFrame: day 0
measure: Clinical success
timeFrame: 1 month
measure: 30-day mortality
timeFrame: 30 days
measure: Quality of life questionnaire
timeFrame: 30 days
measure: cost-effectiveness
timeFrame: 5 years
Other outcomes:
Locations:
city: Besançon
country: France
facility: Rinckenbach
city: Brest
country: France
facility: NASR
city: Créteil
country: France
facility: El Batti
city: Grenoble
country: France
facility: Spear
city: Nantes
country: France
facility: Pr Blandine Maurel
city: Nice
country: France
facility: Jean-Baptiste
city: Reims
country: France
facility: Duprey
Study officials:
References: