Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT02894749

Evaluation of 3D Rotational Angiography After EVAR

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
RADIATION3D 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.

Timeline

Start date
2017-08-01
Primary completion
2019-07-01
Completion
2019-07-01
First posted
2016-09-09
Last updated
2017-12-22

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02894749. Inclusion in this directory is not an endorsement.