Peripheral Arterial DiseasePANORAMICNCT03669978
Endovascular Procedures With Computer Assistance in the Chronic Occlusive Arthritis of the Lower Limbs on the Femoro-popliteal Stage.
An observational study of Peripheral Arterial Disease, run by Rennes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Creation of a bone and arterial panorama using EndoNaut® software.
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2017to 12 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients requiring conventional surgical revascularization.
- Patient under legal protection (guardianship, safeguard of justice).
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Creation of a bone and arterial panorama using EndoNaut® software.
- Keywords
- Occlusive arthritis, bone panorama, arterial panorama
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creation of a bone and arterial panorama using EndoNaut® software.Procedure or surgery
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Creation of a bone and arterial panorama using EndoNaut® software. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the inclusion day
Volume of contrast product used during the routine care procedure (ml)
Volume are reported in mL
Measured: At the inclusion day
Irradiation parameters: evaluation of the Fluoroscopy duration (min)
Parameter given by the X-ray imaging device
Measured: At the inclusion day
Irradiation parameters: dose-area quantification (mGy/m2)
Parameter given by the X-ray imaging device
Measured: At inclusion
Irradiation parameters: measurement of air Kerma (mGy)
Parameter given by the X-ray imaging device
Measured: At the inclusion day
Irradiation parameters: evaluation of the number of required angiograms
Parameter given by the X-ray imaging device
Measured: 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
Measured: At the inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start8 Aug 2017
- Primary completion12 Dec 2017
- Study completion12 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrien Kaladji, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669978
- Sponsor's protocol ID
- 35RC17_3070
- Acronym
- PANORAMIC
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Procedures With Computer Assistance in the Chronic Occlusive Arthritis of the Lower Limbs on the Femoro-popliteal Stage.
- ClinicalTrials.gov ID
- NCT03669978
- Acronym / sponsor ID
- PANORAMIC / 35RC17_3070
- Conditions
- Peripheral Arterial Disease
- Keywords
- Occlusive arthritis, bone panorama, arterial panorama
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic occlusive arthritis of the Lower Limbs | – | Procedure: Creation of a bone and arterial panorama using EndoNaut® software.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients requiring conventional surgical revascularization.
- Patient under legal protection (guardianship, safeguard of justice).
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creation of a bone and arterial panorama using EndoNaut® software.Also: 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. | Procedure or surgery | Patients with chronic occlusive arthritis of the Lower Limbs |
Primary outcome
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
Volume of contrast product used during the routine care procedure (ml)
Time frame: At the inclusion day
Volume are reported in mL
Irradiation parameters: evaluation of the Fluoroscopy duration (min)
Time frame: At the inclusion day
Parameter given by the X-ray imaging device
Irradiation parameters: dose-area quantification (mGy/m2)
Time frame: At inclusion
Parameter given by the X-ray imaging device
Irradiation parameters: measurement of air Kerma (mGy)
Time frame: At the inclusion day
Parameter given by the X-ray imaging device
Irradiation parameters: evaluation of the number of required angiograms
Time frame: At the inclusion day
Parameter given by the X-ray imaging device
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrien Kaladji, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of the registration errors (time frame: At the inclusion day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.