EndovascularRADIOPROTECNCT06590532
Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice
A study testing Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV and Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV in people with Endovascular, run by Nantes University Hospital at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endovascular
- What is being tested?
- Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV and Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 7 sitesFrance
- Study dates
- 10 Dec 2024to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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)
Show all 9Show fewer
- Aortic emergencies (ruptured AAA).
- Persons under guardianship, curatorship or safeguard of justice
- Pregnant or breast-feeding women.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Not yet recruiting
Rinckenbach
Besançon, Besançon, 25000
Simon Rinckenbach, Pr, 03 81 66 80 99, srinckenbach@chu-besancon.fr
Simon Rinckenbach, Pr
- Not yet recruiting
NASR
Brest, Brest, 29200
Bahaa Nasr, Pr, 02 98 22 33 33, nasr.bahaa@gmail.com
Bahaa Nasr, Pr
- Not yet recruiting
El Batti
Créteil, Créteil, 94000
Salma El Batti, Pr, 01 56 09 57 00, salma.elbatti@aphp.fr
Salma El Batti, Pr
- Not yet recruiting
Spear
Grenoble, Grenoble, 38000
Rafaëlle Spear, Pr, 04 76 76 50 26, rafaelle.spear@gmail.com
Rafaëlle Spear, Pr
- Recruiting
Pr Blandine Maurel
Nantes, Nantes, 44000
Blandine Maurel, Pr, 0240165372, blandine.maurel@chu-nantes.fr
Blandine MAUREL, Pr
- Not yet recruiting
Jean-Baptiste
Nice, Nice, 06000
Elixène Jean-Baptiste, Pr, 04 92 03 38 35, jean-baptiste.e@chu-nice.fr
Elixène Jean-Baptiste, Pr
- Not yet recruiting
Duprey
Reims, Reims, 51100
Ambroise Duprey, Pr, 03 26 78 78 78, ambroise.duprey@gmail.com
Ambroise Duprey, Pr
About this study
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.
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
Read the 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.
- Conditions
- Endovascular
- Being 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EVProcedure or surgery
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.
Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EVProcedure or surgery
patients will be assigned either to an endovascular repair using standard X-ray fluoroscopy imaging alone (the current reference standard)
| Study group | Role | What they receive |
|---|---|---|
| Fusion group | Experimental | patient undergoing endovascular aortic repair with fusion imaging system guidance Receives: 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) Receives: Procedure: Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 €.
Measured: 18 month
Secondary outcomes (9)
X-ray dose per procedure
exposure parameters from the machine
Measured: day 0
X-ray dose per procedure for the physician
exposure parameters from the dosimeter
Measured: day 0
Contrast dose per procedure
Contrast dose used
Measured: day 0
Length of ITU/HDU admission
Length of ITU/HDU admission
Measured: 18 months
Technical success
defined as proximal and distal seal zone at least 10mm and no evidence of endoleak or revascularization success.
Measured: day 0
Clinical success
defined as primary patency rate or endovascular exclusion of the aneurysm
Measured: 1 month
30-day mortality
30-day mortality
Measured: 30 days
Quality of life questionnaire
EQ-5D-5L assessement
Measured: 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)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Dec 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndovascularStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590532
- Sponsor's protocol ID
- RC22_0396
- Acronym
- RADIOPROTEC
- Status last verified
- Dec 2024
- First submitted
- 24 Jun 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06590532
- Acronym / sponsor ID
- RADIOPROTEC / RC22_0396
- Conditions
- Endovascular
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fusion group | Experimental | Procedure: Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EVpatient undergoing endovascular aortic repair with fusion imaging system guidance |
| Control group | Active comparator | Procedure: Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EVpatient undergoing endovascular aortic repair without fusion imaging system guidance (only with X-rays and roadmaping) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EVCydar-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 or surgery | Fusion group |
| Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EVpatients will be assigned either to an endovascular repair using standard X-ray fluoroscopy imaging alone (the current reference standard) | Procedure or surgery | Control group |
Primary outcome
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
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 €.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV and Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV in people with Endovascular, run by Nantes University Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Blandine Maurel, Pr (02 40 16 53 72, blandine.maurel@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 18 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.