NCT02894749

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
427

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2017

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

September 5, 2016

Last Update Submit

April 29, 2026

Conditions

Radiation BurnAortic Aneurysm, Abdominal

Keywords

hybrid roomscone-beam computed tomography

Outcome Measures

Primary Outcomes (1)

  • Effective Dose

    Total exposure to radiation in mSv

    Single 1 day - At patient discharge

Secondary Outcomes (3)

  • Contrast Medium

    Single 1 day - At patient discharge

  • Reintervention rate

    During the first 30 days

  • Additional procedure

    During surgery

Study Arms (2)

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.

Radiation: 3D rotational angiography (3DRA)

Interventions

3D rotational angiography (3DRA)RADIATION

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.

Also known as: Cone-beam CT
3D rotational angiography (3DRA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cardiologique, CHRU

Lille, France

Location

Related Publications (1)

  • 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.

    PMID: 28546044RESULT

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Stephan Haulon, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 9, 2016

Study Start

August 1, 2015

Primary Completion

January 6, 2017

Study Completion

January 6, 2017

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)