Radiation BurnEVARNCT02894749
Evaluation of 3D Rotational Angiography After EVAR
A study testing 3D rotational angiography (3DRA) in people with Radiation Burn and Aortic Aneurysm, Abdominal, run by University Hospital, Lille at 1 site in France.
Trial summary
This is a randomized prospective monocentric study to evaluate the benefits of a 3D rotational acquisition (3DRA) to assess technical success after treatment of infra-renal aneurysm with bifurcated endograft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Burn, Aortic Aneurysm, Abdominal
- What is being tested?
- 3D rotational angiography (3DRA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 427 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2015to 6 Jan 2017
- 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
- Patients treated with EVAR for infra-renal aortic aneurysm
- In a hybrid room
- With a signed consent
Who cannot join
- Pregnant women
- Patients unable to understand the study protocol or to give their consents
- Renal insufficiency (eGFR<60mL/min)
- Ruptured aneurysms and other emergency settings
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized prospective monocentric study to evaluate the benefits of a 3D rotational acquisition (3DRA) to assess technical success after treatment of infra-renal aneurysm with bifurcated endograft. Patients will be randomized between the standard strategy (2D angiography at the end of the procedure and angioCT-scan before discharge) and the new strategy (3DRA at the end of the procedure). Expected findings are a reduction of radiation exposure and contrast medium used during the hospital stay, with a similar resolution between angioCT-scan and 3DRA to depict the main complications after EVAR (occlusion, kinking, endoleak). Furthermore, any complication depicted after 3DRA group could benefit from an additional procedure during the same operating time, and therefore avoid a second intervention for the patient.
- Conditions
- Radiation Burn, Aortic Aneurysm, Abdominal
- Being tested
- 3D rotational angiography (3DRA)
- Keywords
- hybrid rooms, cone-beam computed tomography
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D rotational angiography (3DRA)Radiation
Also called Cone-beam CT
3DRA allows CT-like reconstructions. It requires less X-rays and contrast medium than standard angioCT-scan. Furthermore, it can be performed in the operative room, during the procedure. Therefore, use of 3DRA should allow reduction of dose, contrast-medium and reintervention when compared to technical success assessment with angioCT-scan.
| Study group | Role | What they receive |
|---|---|---|
| 2D Angiography (2DA) | No intervention | Standard of care - Patients benefit from a 2D completion angiogram at the end of the procedure, and from a angioCT-scan before discharge. If any technical issues is depicted on the CT-scan, a new intervention needs to be scheduled. |
| 3D rotational angiography (3DRA) | Experimental | New strategy - Patients benefit from a 3D rotational acquisition at the end of procedure, which offers CT-like reconstructions. If any technical issues is depicted on the 3DRA, it can be treated during the same operating time. A contrast-enhanced ultrasound is performed for each patient before discharge to confirm that no technical issue was missed by the 3DRA. Receives: Radiation: 3D rotational angiography (3DRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Dose
Total exposure to radiation in mSv
Measured: Single 1 day - At patient discharge
Secondary outcomes (3)
Contrast Medium
Total amount of contrast medium used (mg of Iodine)
Measured: Single 1 day - At patient discharge
Reintervention rate
Number of secondary procedures due to initial technical issues in both group during the first month
Measured: During the first 30 days
Additional procedure
Number of additional unplanned procedures during the initial operating time, thanks to complications depicted by respectively the 2D angiography or the 3D rotational angiography.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start1 Aug 2015
- Primary completion6 Jan 2017
- Study completion6 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation BurnStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Stephan Haulon, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894749
- Sponsor's protocol ID
- 2014_47
- Other IDs
- 2015-A00645-44
- Acronym
- EVAR
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2016
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clough RE, Martin-Gonzalez T, Van Calster K, Hertault A, Spear R, Azzaoui R, Sobocinski J, Haulon S. Endovascular Repair of Thoracoabdominal and Arch Aneurysms in Patients with Connective Tissue Disease Using Branched and Fenestrated Devices. Ann Vasc Surg. 2017 Oct;44:158-163. doi: 10.1016/j.avsg.2017.05.013. Epub 2017 May 22.
PubMed 28546044
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 3D Rotational Angiography After EVAR
- ClinicalTrials.gov ID
- NCT02894749
- Acronym / sponsor ID
- EVAR / 2014_47
- Conditions
- Radiation Burn, Aortic Aneurysm, Abdominal
- Keywords
- hybrid rooms, cone-beam computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 6 Jan 2017 (actual)
- Study completion
- 6 Jan 2017 (actual)
- First posted
- 9 Sep 2016 (estimated)
- 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.
This is a randomized prospective monocentric study to evaluate the benefits of a 3D rotational acquisition (3DRA) to assess technical success after treatment of infra-renal aneurysm with bifurcated endograft. Patients will be randomized between the standard strategy (2D angiography at the end of the procedure and angioCT-scan before discharge) and the new strategy (3DRA at the end of the procedure). Expected findings are a reduction of radiation exposure and contrast medium used during the hospital stay, with a similar resolution between angioCT-scan and 3DRA to depict the main complications after EVAR (occlusion, kinking, endoleak). Furthermore, any complication depicted after 3DRA group could benefit from an additional procedure during the same operating time, and therefore avoid a second intervention for the patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2D Angiography (2DA) | No intervention | –Standard of care - Patients benefit from a 2D completion angiogram at the end of the procedure, and from a angioCT-scan before discharge. If any technical issues is depicted on the CT-scan, a new intervention needs to be scheduled. |
| 3D rotational angiography (3DRA) | Experimental | Radiation: 3D rotational angiography (3DRA)New strategy - Patients benefit from a 3D rotational acquisition at the end of procedure, which offers CT-like reconstructions. If any technical issues is depicted on the 3DRA, it can be treated during the same operating time. A contrast-enhanced ultrasound is performed for each patient before discharge to confirm that no technical issue was missed by the 3DRA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients treated with EVAR for infra-renal aortic aneurysm
- In a hybrid room
- With a signed consent
Key exclusion criteria (4 listed)
- Pregnant women
- Patients unable to understand the study protocol or to give their consents
- Renal insufficiency (eGFR<60mL/min)
- Ruptured aneurysms and other emergency settings
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 |
|---|---|---|
| 3D rotational angiography (3DRA)Also: Cone-beam CT3DRA allows CT-like reconstructions. It requires less X-rays and contrast medium than standard angioCT-scan. Furthermore, it can be performed in the operative room, during the procedure. Therefore, use of 3DRA should allow reduction of dose, contrast-medium and reintervention when compared to technical success assessment with angioCT-scan. | Radiation | 3D rotational angiography (3DRA) |
Primary outcome
Effective Dose
Time frame: Single 1 day - At patient discharge
Total exposure to radiation in mSv
3 secondary outcomes
Contrast Medium
Time frame: Single 1 day - At patient discharge
Reintervention rate
Time frame: During the first 30 days
Additional procedure
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Results publication: PubMed 28546044Clough RE, Martin-Gonzalez T, Van Calster K, Hertault A, Spear R, Azzaoui R, Sobocinski J, Haulon S. Endovascular Repair of Thoracoabdominal and Arch Aneurysms in Patients with Connective Tissue Disease Using Branched and Fenestrated Devices. Ann Vasc Surg. 2017 Oct;44:158-163. doi: 10.1016/j.avsg.2017.05.013. Epub 2017 May 22.
- 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. This study is not recruiting at the moment.
Stephan Haulon, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D rotational angiography (3DRA) in people with Radiation Burn and Aortic Aneurysm, Abdominal, run by University Hospital, Lille 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 4 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: finished, as of the sponsor's last update on 5 May 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effective Dose (time frame: Single 1 day - At patient discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02894749, which also lists 1 linked publication.
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 5 May 2026.