Skip to main content
OpenTrials
Completed

NCT Number: NCT04709991

Comparison of Lower Limb Endovascular Interventions With and Without the EndoNaut Workstation

To demonstrate that the use of EndoNaut for endovascular procedures on the femoropopliteal axis has a clinical impact for the patient (decrease in irradiation and the volume of contrast product) as well as for nursing staff (reduction in irradiation) compared to procedures performed without EndoNaut.

Completed

Looking for future studies?

Notify Me

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

CH Libourne

Libourne, France

About this study

Peripheral artery disease (PAD) is characterized by a narrowing of the size of arteries, which resulting in a loss of hemodynamic load. Endovascular (or percutaneous) procedures performed at the infrainguinal level (axefemoro-popliteal) are very common in affected patients. Therenva offers a complete and consistent lightweight navigation solution (EndoNaut®) based on artificial intelligence (AI) algorithms, and providing technology accessible to all operating rooms for PAD procedures. The aim of this study is to demonstrate that the use of EndoNaut for endovascular procedures on the femoropopliteal axis has a clinical impact for the patient (decrease in irradiation and the volume of contrast product) as well as for nursing staff (reduction in irradiation) compared to the procedures performed by EndoNaut.

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.

Treatment and study plan

endovascular procedure

Procedure

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

Primary outcomes

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

    Time frame: 1 day At enrollment

    Volume are reported in mL

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

    Time frame: 1 day At enrollment

    Parameter given by the X-ray imaging device

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

    Time frame: 1 day At enrollment

    Parameter given by the X-ray imaging device

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

    Time frame: 1 day At enrollment

    Parameter given by the X-ray imaging device

Sponsors and collaborators

Lead sponsor

Therenva

Industry

Collaborators

  • CH Libourne

Registry information

Acronym: COMPAR-MI

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2021
Registry last updated
Oct 6, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.