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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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
Health authority
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Status Withdrawn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

Study Design


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
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