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

NCT06590532 | Recruiting

• 1 other identifier: RC22_0396
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 7

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

Conditions

Endovascular

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• X-ray dose per procedure

  day 0

• X-ray dose per procedure for the physician

  day 0

• Contrast dose per procedure

  day 0

• Length of ITU/HDU admission

  18 months

• Technical success

  day 0

Study Arms (2)

Fusion group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV PROCEDURE

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.

Fusion group

Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV PROCEDURE

patients will be assigned either to an endovascular repair using standard X-ray fluoroscopy imaging alone (the current reference standard)

Control group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (7)

Rinckenbach

Besançon, Besançon, 25000, France

NOT YET RECRUITING

NASR

Brest, Brest, 29200, France

NOT YET RECRUITING

El Batti

Créteil, Créteil, 94000, France

NOT YET RECRUITING

Spear

Grenoble, Grenoble, 38000, France

NOT YET RECRUITING

Pr Blandine Maurel

Nantes, Nantes, 44000, France

RECRUITING

Jean-Baptiste

Nice, Nice, 06000, France

NOT YET RECRUITING

Duprey

Reims, Reims, 51100, France

NOT YET RECRUITING

MeSH Terms

Interventions

Endovascular Aneurysm Repair

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

Central Study Contacts

Blandine Maurel, Pr

CONTACT

02 40 16 53 72; blandine.maurel@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: September 19, 2024
• Study Start: December 10, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)