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

Peripheral Arterial Disease Clinical Trial

— PANORAMIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669978
• Other study ID #: 35RC17_3070
• Status: Completed
• Start date: August 8, 2017
• Est. completion date: December 12, 2017

Study information

• Verified date: September 2018
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 12, 2017
• Est. primary completion date: December 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Rennes Univesity Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Volume of contrast product used during the routine care procedure (ml)	Volume are reported in mL	At the inclusion day
Primary	Irradiation parameters: evaluation of the Fluoroscopy duration (min)	Parameter given by the X-ray imaging device	At the inclusion day
Primary	Irradiation parameters: dose-area quantification (mGy/m2)	Parameter given by the X-ray imaging device	At inclusion
Primary	Irradiation parameters: measurement of air Kerma (mGy)	Parameter given by the X-ray imaging device	At the inclusion day
Primary	Irradiation parameters: evaluation of the number of required angiograms	Parameter given by the X-ray imaging device	At the inclusion day
Primary	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