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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669978
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669978


Locations
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France
Rennes Univesity Hospital
Rennes, France, 35000
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Adrien Kaladji, MD Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03669978    
Other Study ID Numbers: 35RC17_3070
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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