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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Procedure: Creation of a bone and arterial panorama 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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • Rennes Univesity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.; 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.; Other Names: EndoNaut® software.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Adrien Kaladji, MD, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2017
• Primary Completion (Actual): December 12, 2017
• Study Completion (Actual): December 12, 2017

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Occlusive arthritis; bone panorama; arterial panorama
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Joint Diseases; Musculoskeletal Diseases; Atherosclerosis; Arthritis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 35RC17_3070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No