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

• ClinicalTrials.gov Identifier: NCT03669978
• Recruitment Status: Completed
• First Posted: September 13, 2018
• Last Update Posted: September 13, 2018
• Sponsor: Rennes University Hospital
• Information provided by (Responsible Party): Rennes University Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Peripheral Arterial Disease	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 Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Endovascular Procedures With Computer Assistance in the Chronic Occlusive Arthritis of the Lower Limbs on the Femoro-popliteal Stage.
• Actual Study Start Date: August 8, 2017
• Actual Primary Completion Date: December 12, 2017
• Actual Study Completion Date: December 12, 2017

Groups and Cohorts

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 Name: EndoNaut® software.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

France

Rennes Univesity Hospital

Rennes, France, 35000

Sponsors and Collaborators

Rennes University Hospital

Investigators

• Principal Investigator: Adrien Kaladji, MD; Rennes University Hospital

More Information

• Responsible Party: Rennes University Hospital
• ClinicalTrials.gov Identifier: NCT03669978
• Other Study ID Numbers: 35RC17_3070
• First Posted: September 13, 2018
• Last Update Posted: September 13, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rennes University Hospital:

Occlusive arthritis; bone panorama; arterial panorama

Additional relevant MeSH terms:

Arthritis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Joint Diseases; Musculoskeletal Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases