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Patient and Staff Safety During Aorto-iliac Revascularization Procedures Under Automated Fusion Imaging Guidance With Controls (CYDAR ILIAC)

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ClinicalTrials.gov Identifier: NCT03713450
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

Endovascular revascularization has revolutionized the field of vascular surgery and has become the first-choice treatment for peripheral arteries occlusive disease. However, the drawback of this technic is the X-ray exposure for both patients and staff and the iodinated contrast injection for the patient.

One way to reduce both radiation and contrast use is to use advanced imaging techniques allowing an overlay of a 3D vascular mask (from a pre-operative CT scan) onto the live X-ray image. This has been proven during endovascular aneurysm repair.

This advanced imaging application is currently available only in the latest expensive hybrid operating rooms, requires additional manoeuvre from the operator throughout the procedure, and may be X-rays and contrast consuming.

This trial will examine the clinical benefits based on patient and staff' radiation exposure during aorto-iliac revascularisation, of a new software imaging guidance, suitable for any theatre including those equipped with mobile C-arm, fully automated and with a radiation free overlay registration process.


Condition or disease Intervention/treatment Phase
Patient and Staff Radiation Exposure During Aorto-iliac Endovascular Revascularization Device: Control with imaging guidance Device: Control without imaging guidance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Prospective Single Centre Randomized Interventional Controlled Trial Comparing Patient and Staff Safety During Aorto-iliac Revascularization Procedures Under Automated Fusion Imaging Guidance With Controls
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Control with imaging guidance Device: Control with imaging guidance

Prospective randomized study during aorto-iliac revascularisation comparing patient and staff radiation exposure using the automated overlay imaging guidance, in addition to the application of the ALARA principles.

The study includes only the per-operative period but no follow-up. The study will be performed in all imaging environment (Hybrid room or mobile).


Active Comparator: Control without imaging guidance Device: Control without imaging guidance

Prospective randomized study during aorto-iliac revascularisation comparing patient and staff radiation exposure not using the automated overlay imaging guidance, in addition to the application of the ALARA principles.

The study includes only the per-operative period but no follow-up. The study will be performed in all imaging environment (Hybrid room or mobile).





Primary Outcome Measures :
  1. Dose area product [ Time Frame: The end of the procedure ]
    Dose area product (DAP) by the end of the procedure.


Secondary Outcome Measures :
  1. Number of DSA runs [ Time Frame: The end of the procedure ]
    Number of DSA runs by the end of the procedure.

  2. Air Kerma [ Time Frame: The end of the procedure ]
    Air Kerma (mGy) by the end of the procedure.

  3. Fluoroscopy time [ Time Frame: The end of the procedure ]
    Fluoroscopy time (min) by the end of the procedure.

  4. Contrast volume [ Time Frame: The end of the procedure ]
    Contrast volume (ml) by the end of the procedure.

  5. Operative time [ Time Frame: The end of the procedure ]
    Operative time (min) by the end of the procedure.

  6. Operator exposure [ Time Frame: The end of the procedure ]
    Operator exposure (Sv) by the end of the procedure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged 18 or older,
  • Patients scheduled for aorto iliac endovascular revascularisation,
  • Pre-operative CT scan.

Exclusion Criteria:

  • Women of childbearing age,
  • Absence of preoperative CT scan,
  • Emergency procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713450


Contacts
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Contact: Blandine MAUREL, Doctor 02 40 16 53 72 ext +33 blandine.maurel@chu-nantes.fr

Locations
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France
Nantes University Hospital, Vascular surgery, Institut du Thorax Recruiting
Nantes, France, 44093
Contact: Blandine MAUREL, MD         
Principal Investigator: Blandine MAUREL, MD         
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03713450     History of Changes
Other Study ID Numbers: RC18_0092
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nantes University Hospital:
Radiation
Contrast
Endovascular
Fusion imaging guidance
Iliac