Patient and Staff Radiation Exposure During Aorto-iliac Endovascular RevascularizationCYDAR ILIACNCT03713450
Patient and Staff Safety During Aorto-iliac Revascularization Procedures Under Automated Fusion Imaging Guidance With Controls
A study of Patient and Staff Radiation Exposure During Aorto-iliac Endovascular Revascularization, run by Nantes University Hospital at 1 site in France.
Trial summary
Endovascular revascularization has revolutionized the field of vascular surgery and has become the first-choice treatment for peripheral arteries occlusive disease. However, the drawback of this technic is the X-ray exposure for both patients and staff and the iodinated contrast injection for the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient and Staff Radiation Exposure During Aorto-iliac Endovascular Revascularization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2019to 7 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male or female aged 18 or older,
- Patients scheduled for aorto iliac endovascular revascularisation,
- Pre-operative CT scan.
Who cannot join
- Women of childbearing age,
- Absence of preoperative CT scan,
- Emergency procedures.
Trial locations and contacts
1 site in 1 country.
France1 site
Nantes University Hospital, Vascular surgery, Institut du Thorax
Nantes, 44093
About this study
Official title: A Prospective Single Centre Randomized Interventional Controlled Trial Comparing Patient and Staff Safety During Aorto-iliac Revascularization Procedures Under Automated Fusion Imaging Guidance With Controls
Endovascular revascularization has revolutionized the field of vascular surgery and has become the first-choice treatment for peripheral arteries occlusive disease. However, the drawback of this technic is the X-ray exposure for both patients and staff and the iodinated contrast injection for the patient.
One way to reduce both radiation and contrast use is to use advanced imaging techniques allowing an overlay of a 3D vascular mask (from a pre-operative CT scan) onto the live X-ray image. This has been proven during endovascular aneurysm repair.
Read more
This advanced imaging application is currently available only in the latest expensive hybrid operating rooms, requires additional manoeuvre from the operator throughout the procedure, and may be X-rays and contrast consuming.
This trial will examine the clinical benefits based on patient and staff' radiation exposure during aorto-iliac revascularisation, of a new software imaging guidance, suitable for any theatre including those equipped with mobile C-arm, fully automated and with a radiation free overlay registration process.
- Being tested
- Control with imaging guidance, Control without imaging guidance
- Keywords
- Radiation, Contrast, Endovascular, Fusion imaging guidance, Iliac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control with imaging guidanceDevice
Prospective randomized study during aorto-iliac revascularisation comparing patient and staff radiation exposure using the automated overlay imaging guidance, in addition to the application of the ALARA principles.
The study includes only the per-operative period but no follow-up. The study will be performed in all imaging environment (Hybrid room or mobile).
Control without imaging guidanceDevice
Prospective randomized study during aorto-iliac revascularisation comparing patient and staff radiation exposure not using the automated overlay imaging guidance, in addition to the application of the ALARA principles.
The study includes only the per-operative period but no follow-up. The study will be performed in all imaging environment (Hybrid room or mobile).
| Study group | Role | What they receive |
|---|---|---|
| Control with imaging guidance | Experimental | Not described Receives: Device: Control with imaging guidance |
| Control without imaging guidance | Active comparator | Not described Receives: Device: Control without imaging guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose area product
Dose area product (DAP) by the end of the procedure.
Measured: The end of the procedure
Secondary outcomes (6)
Number of DSA runs
Number of DSA runs by the end of the procedure.
Measured: The end of the procedure
Air Kerma
Air Kerma (mGy) by the end of the procedure.
Measured: The end of the procedure
Fluoroscopy time
Fluoroscopy time (min) by the end of the procedure.
Measured: The end of the procedure
Contrast volume
Contrast volume (ml) by the end of the procedure.
Measured: The end of the procedure
Operative time
Operative time (min) by the end of the procedure.
Measured: The end of the procedure
Operator exposure
Operator exposure (Sv) by the end of the procedure.
Measured: The end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start10 Jan 2019
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
Why it stopped: Premature termination of the research following an internal reorganization of the team no longer allowing the necessary resources to continue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient and Staff Radiation Exposure During Aorto-iliac Endovascular RevascularizationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713450
- Sponsor's protocol ID
- RC18_0092
- Acronym
- CYDAR ILIAC
- Status last verified
- May 2023
- First submitted
- 18 Oct 2018
- Last updated
- 23 May 2023
- 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 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Centre Randomized Interventional Controlled Trial Comparing Patient and Staff Safety During Aorto-iliac Revascularization Procedures Under Automated Fusion Imaging Guidance With Controls
- ClinicalTrials.gov ID
- NCT03713450
- Acronym / sponsor ID
- CYDAR ILIAC / RC18_0092
- Keywords
- Radiation, Contrast, Endovascular, Fusion imaging guidance, Iliac
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Premature termination of the research following an internal reorganization of the team no longer allowing the necessary resources to continue the study
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 19 Oct 2018 (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.
Endovascular revascularization has revolutionized the field of vascular surgery and has become the first-choice treatment for peripheral arteries occlusive disease. However, the drawback of this technic is the X-ray exposure for both patients and staff and the iodinated contrast injection for the patient.
One way to reduce both radiation and contrast use is to use advanced imaging techniques allowing an overlay of a 3D vascular mask (from a pre-operative CT scan) onto the live X-ray image. This has been proven during endovascular aneurysm repair.
This advanced imaging application is currently available only in the latest expensive hybrid operating rooms, requires additional manoeuvre from the operator throughout the procedure, and may be X-rays and contrast consuming.
This trial will examine the clinical benefits based on patient and staff' radiation exposure during aorto-iliac revascularisation, of a new software imaging guidance, suitable for any theatre including those equipped with mobile C-arm, fully automated and with a radiation free overlay registration process.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control with imaging guidance | Experimental | Device: Control with imaging guidance |
| Control without imaging guidance | Active comparator | Device: Control without imaging guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged 18 or older,
- Patients scheduled for aorto iliac endovascular revascularisation,
- Pre-operative CT scan.
Key exclusion criteria (3 listed)
- Women of childbearing age,
- Absence of preoperative CT scan,
- Emergency procedures.
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 |
|---|---|---|
| Control with imaging guidanceProspective randomized study during aorto-iliac revascularisation comparing patient and staff radiation exposure using the automated overlay imaging guidance, in addition to the application of the ALARA principles. The study includes only the per-operative period but no follow-up. The study will be performed in all imaging environment (Hybrid room or mobile). | Device | Control with imaging guidance |
| Control without imaging guidanceProspective randomized study during aorto-iliac revascularisation comparing patient and staff radiation exposure not using the automated overlay imaging guidance, in addition to the application of the ALARA principles. The study includes only the per-operative period but no follow-up. The study will be performed in all imaging environment (Hybrid room or mobile). | Device | Control without imaging guidance |
Primary outcome
Dose area product
Time frame: The end of the procedure
Dose area product (DAP) by the end of the procedure.
6 secondary outcomes
Number of DSA runs
Time frame: The end of the procedure
Air Kerma
Time frame: The end of the procedure
Fluoroscopy time
Time frame: The end of the procedure
Contrast volume
Time frame: The end of the procedure
Operative time
Time frame: The end of the procedure
Operator exposure
Time frame: The end of the procedure
Results and safety
The study was stopped early (reason given: Premature termination of the research following an internal reorganization of the team no longer allowing the necessary resources to continue the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Patient and Staff Radiation Exposure During Aorto-iliac Endovascular Revascularization, run by Nantes University Hospital at 1 site 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Premature termination of the research following an internal reorganization of the team no longer allowing the necessary resources to continue the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose area product (time frame: The end of the procedure). 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 23 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.