Comparison of Lower Limb Endovascular Interventions With and Without the EndoNaut Workstation
COMPAR-MI
1 other identifier
observational
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 12, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedOctober 6, 2021
October 1, 2021
2.5 years
January 12, 2021
October 5, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
Volume of contrast product used during the routine care procedure (ml)
Volume are reported in mL
1 day At enrollment
Irradiation parameters: evaluation of the Fluoroscopy duration (min)
Parameter given by the X-ray imaging device
1 day At enrollment
Irradiation parameters: dose-area quantification (mGy/m2)
Parameter given by the X-ray imaging device
1 day At enrollment
Irradiation parameters: measurement of air Kerma (mGy)
Parameter given by the X-ray imaging device
1 day At enrollment
Study Arms (2)
Procedures with EndoNaut
Procedures without Endonaut
Interventions
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.
Eligibility Criteria
Patients with chronic occlusive arthritis of the Lower Limbs with lesions on the femoro-popliteal stage and candidates for endovascular treatment of these lesions.
You may qualify if:
- 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
You may not qualify if:
- \- Patients requiring conventional surgical revascularization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Therenvalead
- CH Libournecollaborator
Study Sites (1)
CH Libourne
Libourne, France
Related Publications (1)
Caradu C, Stenson K, Houmaida H, Le Ny J, Lalys F, Ducasse E, Gheysens B. EndoNaut two-dimensional fusion imaging with a mobile C-arm for endovascular treatment of occlusive peripheral arterial disease. J Vasc Surg. 2022 Feb;75(2):651-659.e1. doi: 10.1016/j.jvs.2021.08.069. Epub 2021 Sep 10.
PMID: 34509588DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2021
First Posted
January 14, 2021
Study Start
January 1, 2019
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
October 6, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share