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

Key facts

Who runs it
Nantes University Hospital
Where
Besançon, Brest, Créteil, Grenoble, Nantes, Nice, and Reims, FranceSee the 7 sites
Trial code
Status
Recruiting
People taking part
350 people, planned
Started
10 Dec 2024
Planned end
1 May 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV
  • Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV
Record updated
19 December 2024

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in France

  • RinckenbachBesançon, FranceContact: Simon Rinckenbach, PrNot yet recruiting
  • NASRBrest, FranceContact: Bahaa Nasr, PrNot yet recruiting
  • El BattiCréteil, FranceContact: Salma El Batti, PrNot yet recruiting
  • SpearGrenoble, FranceContact: Rafaëlle Spear, PrNot yet recruiting
  • Pr Blandine MaurelNantes, FranceContact: Blandine Maurel, PrTaking people
  • Jean-BaptisteNice, FranceContact: Elixène Jean-Baptiste, PrNot yet recruiting
  • DupreyReims, FranceContact: Ambroise Duprey, PrNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The 2 groups in the trial

  • Fusion groupTreatment being tested

    patient undergoing endovascular aortic repair with fusion imaging system guidance

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

  • Control groupExisting treatment, for comparison

    patient undergoing endovascular aortic repair without fusion imaging system guidance (only with X-rays and roadmaping)

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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.
Record updated
19 December 2024