Evaluation of 3D Rotational Angiography After EVAR

Aortic Aneurysm, Abdominal Clinical Trial

— EVAR  

Official title:

Evaluation of 3D Rotational Angiography After EVAR

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02894749
• Other study ID #: 2014_47
• Secondary ID: 2015-A00645-44
• Status: Withdrawn
• Phase: N/A
• First received: September 5, 2016
• Last updated: December 21, 2017
• Start date: August 2017
• Est. completion date: July 2019

Study information

• Verified date: December 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Radiation Burn

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Cardiologique, CHRU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	GE Healthcare

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective Dose	Total exposure to radiation in mSv	Single 1 day - At patient discharge
Secondary	Contrast Medium	Total amount of contrast medium used (mg of Iodine)	Single 1 day - At patient discharge
Secondary	Reintervention rate	Number of secondary procedures due to initial technical issues in both group during the first month	During the first 30 days
Secondary	Additional procedure	Number of additional unplanned procedures during the initial operating time, thanks to complications depicted by respectively the 2D angiography or the 3D rotational angiography.	During surgery