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

NCT03669978 | Completed

• 1 other identifier: 35RC17_3070
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

Occlusive arthritis; bone panorama; arterial panorama

Outcome Measures

Primary Outcomes (7)

• Quantification of the registration errors

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

  At the inclusion day

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

  Volume are reported in mL

  At the inclusion day

• Irradiation parameters: evaluation of the Fluoroscopy duration (min)

  Parameter given by the X-ray imaging device

  At the inclusion day

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

  Parameter given by the X-ray imaging device

  At inclusion

• Irradiation parameters: measurement of air Kerma (mGy)

  Parameter given by the X-ray imaging device

  At the inclusion day

• Irradiation parameters: evaluation of the number of required angiograms

  Parameter given by the X-ray imaging device

  At the inclusion day

• Operating time (min)

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

  At the inclusion day

Study Arms (1)

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.

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

Interventions

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.

Also known as: EndoNaut® software.

Patients with chronic occlusive arthritis of the Lower Limbs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.
• Patient under legal protection (guardianship, safeguard of justice).
• Pregnant or lactating women

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes Univesity Hospital

Rennes, 35000, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Adrien Kaladji, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 13, 2018
• Study Start: August 8, 2017
• Primary Completion: December 12, 2017
• Study Completion: December 12, 2017
• Last Updated: September 13, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)