Chronic Limb IschemiaNCT03847597
Histological and Imaging Assessment of the Structural Characteristics of the Femoro-popliteal Arterial Segment
An observational study of Chronic Limb Ischemia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The femoro-popliteal arterial segment is one of the most frequent locations for atherosclerosis. Its management is mainly endovascular (standard and coated-balloon angioplasty, stenting). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Limb Ischemia
- What is being tested?
- Explantation of the femoro-popliteal arterial segment from the amputed limb
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2019to Feb 2022
- 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 limb ischemia that are scheduled for transfemoral amputation
Who may be able to join
- Age > 18 years old
- Men and women
- Patient with chronic limb ischemia that is scheduled for transfemoral amputation in the University Hospital of Strasbourg
- Patient giving his -non-opposition to the explantation and use of the femoro-popliteal arterial segment
Who cannot join
- Refusal to give his consent
- Impossibility to give clear information to the patient
- Pregnant and breastfeeding women
- Patient under administrative protection
Trial locations and contacts
1 site in 1 country.
France1 site
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Nabil CHAKFE, + 33 3 69 55 08 88, nabil.chakfe@chru-strasbourg.fr
Fabien THAVEAU
About this study
The femoro-popliteal arterial segment is one of the most frequent locations for atherosclerosis. Its management is mainly endovascular (standard and coated-balloon angioplasty, stenting).
However, the structural features of the atherosclerotic disease in regards to patient's risk factors and past medical and surgical histories are not well studied. Furthermore, the histological analysis of the femoro-popliteal arterial segment is rare in the literature, and made difficult mostly because of the length of this segment.
There is a clinical need for better understanding of atherosclerotic lesions in this location, with as further goal, a better management of this disease.
- Conditions
- Chronic Limb Ischemia
- Being tested
- Explantation of the femoro-popliteal arterial segment from the amputed limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Explantation of the femoro-popliteal arterial segment from the amputed limbProcedure or surgery
Explantation of the femoro-popliteal arterial segment from the amputed limb
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive analysis of the arterial structure in micro-CT.
study precisely the pathological structure of the femoro-popliteal arterial segment in AOMI, both in imaging and histologically.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study startApr 2019 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Limb IschemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nabil CHAKFE, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847597
- Sponsor's protocol ID
- 7168
- Status last verified
- Dec 2018
- First submitted
- 18 Dec 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological and Imaging Assessment of the Structural Characteristics of the Femoro-popliteal Arterial Segment
- ClinicalTrials.gov ID
- NCT03847597
- Acronym / sponsor ID
- 7168
- Conditions
- Chronic Limb Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 20 Feb 2019 (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.
The femoro-popliteal arterial segment is one of the most frequent locations for atherosclerosis. Its management is mainly endovascular (standard and coated-balloon angioplasty, stenting).
However, the structural features of the atherosclerotic disease in regards to patient's risk factors and past medical and surgical histories are not well studied. Furthermore, the histological analysis of the femoro-popliteal arterial segment is rare in the literature, and made difficult mostly because of the length of this segment.
There is a clinical need for better understanding of atherosclerotic lesions in this location, with as further goal, a better management of this disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic limb ischemia that are scheduled for transfemoral amputation
Key inclusion criteria (4 listed)
- Age > 18 years old
- Men and women
- Patient with chronic limb ischemia that is scheduled for transfemoral amputation in the University Hospital of Strasbourg
- Patient giving his -non-opposition to the explantation and use of the femoro-popliteal arterial segment
Key exclusion criteria (4 listed)
- Refusal to give his consent
- Impossibility to give clear information to the patient
- Pregnant and breastfeeding women
- Patient under administrative protection
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 |
|---|---|---|
| Explantation of the femoro-popliteal arterial segment from the amputed limbExplantation of the femoro-popliteal arterial segment from the amputed limb | Procedure or surgery | – |
Primary outcome
Descriptive analysis of the arterial structure in micro-CT.
Time frame: 3 years
study precisely the pathological structure of the femoro-popliteal arterial segment in AOMI, both in imaging and histologically.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
Nabil CHAKFE principal investigator
Les Hôpitaux Universitaires de Strasbourg
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 Chronic Limb Ischemia, run by University Hospital, Strasbourg, France 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nabil CHAKFE (+33 3 69 55 08 88, nabil.chakfe@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive analysis of the arterial structure in micro-CT. (time frame: 3 years). 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 26 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.