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Evaluation of 3D Rotational Angiography After EVAR (EVAR)

Primary Purpose

Radiation Burn, Aortic Aneurysm, Abdominal

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
3D rotational angiography (3DRA)
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Radiation Burn focused on measuring hybrid rooms, cone-beam computed tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Cardiologique, CHRU

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

2D Angiography (2DA)

3D rotational angiography (3DRA)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Effective Dose
Total exposure to radiation in mSv

Secondary Outcome Measures

Contrast Medium
Total amount of contrast medium used (mg of Iodine)
Reintervention rate
Number of secondary procedures due to initial technical issues in both group during the first month
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.

Full Information

First Posted
September 5, 2016
Last Updated
December 21, 2017
Sponsor
University Hospital, Lille
Collaborators
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02894749
Brief Title
Evaluation of 3D Rotational Angiography After EVAR
Acronym
EVAR
Official Title
Evaluation of 3D Rotational Angiography After EVAR
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator departure (and wish not set up study)
Study Start Date
August 2017 (Anticipated)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
GE Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Burn, Aortic Aneurysm, Abdominal
Keywords
hybrid rooms, cone-beam computed tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2D Angiography (2DA)
Arm Type
No Intervention
Arm Description
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.
Arm Title
3D rotational angiography (3DRA)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
3D rotational angiography (3DRA)
Other Intervention Name(s)
Cone-beam CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effective Dose
Description
Total exposure to radiation in mSv
Time Frame
Single 1 day - At patient discharge
Secondary Outcome Measure Information:
Title
Contrast Medium
Description
Total amount of contrast medium used (mg of Iodine)
Time Frame
Single 1 day - At patient discharge
Title
Reintervention rate
Description
Number of secondary procedures due to initial technical issues in both group during the first month
Time Frame
During the first 30 days
Title
Additional procedure
Description
Number of additional unplanned procedures during the initial operating time, thanks to complications depicted by respectively the 2D angiography or the 3D rotational angiography.
Time Frame
During surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Haulon, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Cardiologique, CHRU
City
Lille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of 3D Rotational Angiography After EVAR

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