Peripheral Arterial Disease Clinical Trial
— PANORAMICOfficial title:
Endovascular Procedures With Computer Assistance in the Chronic Occlusive Arthritis of the Lower Limbs on the Femoro-popliteal Stage.
Verified date | September 2018 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Rennes Univesity Hospital | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
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 |
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