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Completed

NCT Number: NCT03669978

Endovascular Procedures With Computer Assistance in the Chronic Occlusive Arthritis of the Lower Limbs on the Femoro-popliteal Stage.

Pilot study to assess the feasibility of creation of a bone and arterial panorama by 2D-2D registration technique during endovascular femoro-popliteal procedures with a mobile C-arm X-ray system using EndoNaut® software.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rennes Univesity Hospital

Rennes, 35000, France

About this study

The aim of this study is to show that it is possible to give a complete image of the area to be operated by the surgeon by creating a complete bone and arterial panorama of the femoro-popliteal axis with 2D-2D registration techniques. This study should have a clinical impact for the patient and caregiver. With this technique, we expect a reduction in the irradiation of the patient and the caregivers, a decrease in the volume of injected contrast product and a decrease in operating time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with peripheral arterial disease of the lower limbs, all clinical stages, lesions of the femoro-popliteal stage and candidates for endovascular treatment of these lesions.
  • Major patients
  • Patients not opposed to their participation in the study

Exclusion criteria

  • Patients requiring conventional surgical revascularization.
  • Patient under legal protection (guardianship, safeguard of justice).
  • Pregnant or lactating women

Treatment and study plan

Creation of a bone and arterial panorama using EndoNaut® software.

Procedure

The routine care procedure begins with staged injections of contrast medium to provide a map of the lesions. The lesions are then treated by angioplasty with or without stenting.

New injections of contrast product are made to control the results of the treatment.

As part of this pilot study, the assistive software and its interface will be linked and with the mobile C-arm X-ray system. Scopic images and angiograms will be retransmitted to be processed by the EndoNaut® software.

Other names: EndoNaut® software.

Primary outcomes

  1. Quantification of the registration errors

    Time frame: At the inclusion day

    The 2D-2D registration is driven by an error index (intrinsic software criterion) given by the software at the end of the registration process

  2. Volume of contrast product used during the routine care procedure (ml)

    Time frame: At the inclusion day

    Volume are reported in mL

  3. Irradiation parameters: evaluation of the Fluoroscopy duration (min)

    Time frame: At the inclusion day

    Parameter given by the X-ray imaging device

  4. Irradiation parameters: dose-area quantification (mGy/m2)

    Time frame: At inclusion

    Parameter given by the X-ray imaging device

  5. Irradiation parameters: measurement of air Kerma (mGy)

    Time frame: At the inclusion day

    Parameter given by the X-ray imaging device

  6. Irradiation parameters: evaluation of the number of required angiograms

    Time frame: At the inclusion day

    Parameter given by the X-ray imaging device

  7. Operating time (min)

    Time frame: At the inclusion day

    Delay between the beginning (patient anesthesia) and the end (patient transferred to post interventional care room) of the procedure

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: PANORAMIC

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 13, 2018
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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