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

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT03669978
• Lead Sponsor: Rennes University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-08-08
• Primary Completion: 2017-12-12
• Study Completion: 2017-12-12
• Status Verified: 2018-09
• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-11
• Last Update Submitted: 2018-09-11
• Study First Posted: 2018-09-13
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Volume of contrast product used during the routine care procedure (ml)	At the inclusion day	Volume are reported in mL
Irradiation parameters: evaluation of the Fluoroscopy duration (min)	At the inclusion day	Parameter given by the X-ray imaging device
Irradiation parameters: dose-area quantification (mGy/m2)	At inclusion	Parameter given by the X-ray imaging device
Quantification of the registration errors	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
Irradiation parameters: measurement of air Kerma (mGy)	At the inclusion day	Parameter given by the X-ray imaging device
Irradiation parameters: evaluation of the number of required angiograms	At the inclusion day	Parameter given by the X-ray imaging device
Operating time (min)	At the inclusion day	Delay between the beginning (patient anesthesia) and the end (patient transferred to post interventional care room) of the procedure

Trial Locations

Locations (1)

Rennes Univesity Hospital; 🇫🇷 Rennes, France