Trials / Withdrawn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- Withdrawn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
| Type | Name | Description |
|---|---|---|
| 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. |
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.