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OpenTrials
Completed

NCT Number: NCT02894749

Evaluation of 3D Rotational Angiography After 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.

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Key information

Conditions

Radiation Burn Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Cardiologique, CHRU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Cone-beam CT

Primary outcomes

  1. Effective Dose

    Time frame: Single 1 day - At patient discharge

    Total exposure to radiation in mSv

Secondary outcomes

  1. Contrast Medium

    Time frame: Single 1 day - At patient discharge

    Total amount of contrast medium used (mg of Iodine)

  2. Reintervention rate

    Time frame: During the first 30 days

    Number of secondary procedures due to initial technical issues in both group during the first month

  3. Additional procedure

    Time frame: During surgery

    Number of additional unplanned procedures during the initial operating time, thanks to complications depicted by respectively the 2D angiography or the 3D rotational angiography.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • GE Healthcare

Registry information

Acronym: EVAR

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 9, 2016
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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