Safety of Fusion Guidance During Peripheral Revascularisation

NCT03546881 | Terminated

• 1 other identifier: RC17_0473
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Study the Patient and staff Safety regarding the radiation exposure during the procedure with and without the fusion imaging guidance technology in treatment of peripheral artery disease.

Conditions

Arteriopathy

Keywords

PAOD; endovascular; fusion; radiation; exposure

Outcome Measures

Primary Outcomes (1)

• DAP (Dose Aera Product in Gy.cm²) by the end of the procedure,

  The DAP is a surrogate measurement for the entire amount of energy delivered to the patient by the beam.

  day 0, per procedure

Secondary Outcomes (6)

• AK (Air Kerma, in Gy)

  day 0, per procedure

• Number of DSA (Digital Subtraction Angiography) runs

  day 0, per procedure

• FT (Fluoroscopy Time, min).

  day 0, per procedure

• Radiation exposure to the operator (Sv).

  day 0, per procedure

• Iodinated contrast volume (ml).

  day 0, per procedure

Study Arms (2)

Arm with fusion imaging guidance technology

EXPERIMENTAL

arm with fusion imaging guidance technology to perform the endovascular surgery, in addition to the traditional 2D X-ray screen system.

Procedure: fusion imaging guidance technology; Procedure: 2D X-ray screen

Arm without fusion imaging guidance technology

ACTIVE COMPARATOR

arm without fusion imaging guidance technology, using the traditional 2D X-ray screen system, to perform the endovascular surgery.

Procedure: 2D X-ray screen

Interventions

fusion imaging guidance technology PROCEDURE

Imaging fusion guidance overlay used during PAOD endovascular revascularisation

Arm with fusion imaging guidance technology

2D X-ray screen PROCEDURE

2D X-ray screen during PAOD endovascular revascularisation

Arm with fusion imaging guidance technology; Arm without fusion imaging guidance technology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give informed consent
• Male or Female
• Aged 18 or older
• Have been scheduled for peripheral endovascular revascularisation of an occlusive arterial disease excluding isolated infra popliteal revascularisation
• Who have had a pre-operative diagnostic CT scan
• Able (in the investigator's opinion) and willing to comply with the study requirements
• Covered by the French public health insurance system

You may not qualify if:

• Female under the age of 50 years old.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
• Any patient requiring an associated procedure: renal or mesenteric angioplasty.
• Adult under guardianship or trusteeship

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital, Vascular surgery, Institut du Thorax

Nantes, 44093, France

Location

Study Officials

• Blandine Maurel, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 6, 2018
• Study Start: June 18, 2018
• Primary Completion: October 16, 2019
• Study Completion: October 16, 2019
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

FR (1)