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Evaluation of 3D Rotational Angiography After EVAR

NCT ID: NCT02894749

Last Updated: 2017-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2019-07-31

Brief Summary

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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

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Conditions

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Radiation Burn Aortic Aneurysm, Abdominal

Keywords

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hybrid rooms cone-beam computed tomography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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2D Angiography (2DA)

Standard of care - Patients benefit from a 2D completion angiogram at the end of the procedure, and from a angioCT-scan before discharge. If any technical issues is depicted on the CT-scan, a new intervention needs to be scheduled.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

3D rotational angiography (3DRA)

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Other Intervention Names

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Cone-beam CT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephan Haulon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Cardiologique, CHRU

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2015-A00645-44

Identifier Type: OTHER

Identifier Source: secondary_id

2014_47

Identifier Type: -

Identifier Source: org_study_id