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

NCT ID: NCT03669978

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-08
• Study Completion Date: 2017-12-12

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.

Conditions

Peripheral Arterial Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with chronic occlusive arthritis of the Lower Limbs

Patients with chronic occlusive arthritis of the Lower Limbs with lesions on the femoro-popliteal stage and candidates for endovascular treatment of these lesions.

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

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

Intervention Type: 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.

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.

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.

Intervention Type: PROCEDURE

Other Intervention Names

EndoNaut® software.

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrien Kaladji, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Rennes Univesity Hospital

Rennes, , France

Countries

France

Other Identifiers

35RC17_3070

Identifier Type: -

Identifier Source: org_study_id