Evaluation of 3D Rotational Angiography After EVAR (EVAR)

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 Overview

• Status: Completed
• Conditions: Aortic Aneurysm, Abdominal; Radiation Burn
• Intervention / Treatment: Radiation: 3D rotational angiography (3DRA)

• Study Type: Interventional
• Enrollment (Actual): 427
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Cardiologique, CHRU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients treated with EVAR for infra-renal aortic aneurysm
• In a hybrid room
• With a signed consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 2D Angiography (2DA); 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.
Experimental: 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.	Radiation: 3D rotational angiography (3DRA); 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.; Other Names: Cone-beam CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective Dose	Total exposure to radiation in mSv	Single 1 day - At patient discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast Medium	Total amount of contrast medium used (mg of Iodine)	Single 1 day - At patient discharge
Reintervention rate	Number of secondary procedures due to initial technical issues in both group during the first month	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.	During surgery

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: GE Healthcare
• Investigators: Principal Investigator: Stephan Haulon, MD, PhD, University Hospital, Lille

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): January 6, 2017
• Study Completion (Actual): January 6, 2017

Study Registration Dates

• First Submitted: September 5, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimated): September 9, 2016

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: hybrid rooms; cone-beam computed tomography
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 2014_47; 2015-A00645-44 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No