Evaluation of 3D Rotational Angiography After EVAR

Not Applicable

Withdrawn

• Conditions: Radiation Burn; Aortic Aneurysm, Abdominal
• Interventions: Radiation: 3D rotational angiography (3DRA)

• Registration Number: NCT02894749
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-09
• Study Start: 2017-08
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-21
• Last Update Posted: 2017-12-22
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D rotational angiography (3DRA)	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.

Primary Outcome Measures

Name	Time	Method
Effective Dose	Single 1 day - At patient discharge	Total exposure to radiation in mSv

Secondary Outcome Measures

Name	Time	Method
Reintervention rate	During the first 30 days	Number of secondary procedures due to initial technical issues in both group during the first month
Contrast Medium	Single 1 day - At patient discharge	Total amount of contrast medium used (mg of Iodine)
Additional procedure	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.

Trial Locations

Locations (1)

Hôpital Cardiologique, CHRU; 🇫🇷 Lille, France