Peripheral Arterial Occlusive DiseaseMERLLABNCT07093632
Medium-term Results of Lower Limb Arterial Bypass
An observational study of Peripheral Arterial Occlusive Disease and Critical Limb Ischemia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Peripheral arterial occlusive disease (PAOD) is a condition affecting the arteries of the lower limbs, caused by the progressive accumulation of lipid deposits that obstruct blood vessels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Occlusive Disease, Critical Limb Ischemia, Arterial Revascularization
- What is being tested?
- Graft dysfunction will be assessed through clinical examination and imaging follow-up to detect occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the treated limb.
- Type of treatment
- Surgery or procedure
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2025to 1 Apr 2025
- 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: This study concerns adult subjects with symptomatic lower limb arterial disease who have undergone arterial bypass surgery.
Who may be able to join
- Adults aged over 18 years
- Symptomatic lower limb arterial disease
- Undergoing revascularization bypass surgery
Who cannot join
- Patients who have expressed opposition to the use of their data for research purposes
Trial locations and contacts
1 site in 1 country.
About this study
Peripheral arterial occlusive disease (PAOD) is a condition affecting the arteries of the lower limbs, caused by the progressive accumulation of lipid deposits that obstruct blood vessels. At an advanced stage, PAOD may progress to critical limb ischemia (CLI), characterized by persistent pain, chronic wounds, or gangrene. This situation constitutes a medical emergency, as it may result in limb loss or threaten the life of the patient.
In this context, arterial revascularization is essential to restore adequate blood flow to the tissues. Among therapeutic options, arterial bypass surgery remains a reference strategy. The choice of bypass type, the material used (autologous vein or prosthetic graft), perioperative conditions, and clinical characteristics of patients significantly influence the success of the intervention and both short- and long-term outcomes.
Read more
When an autologous vein is not available, the use of cold-stored allogeneic vein grafts has been proposed as an alternative. Several studies have evaluated their performance, showing encouraging results in terms of graft patency and limb salvage in patients with CLI. More recently, the REVATEC study confirmed these observations in a multicenter setting in France, highlighting the feasibility and safety of this technique in routine clinical practice].
Thus, a better understanding of the factors associated with the performance of arterial bypasses and the clinical evolution of patients in real-world practice is essential to optimize management strategies.
This retrospective study aims to analyze the clinical and technical data related to arterial bypass procedures performed in patients presenting with CLI. Data will be collected at various stages of the care pathway: preoperative phase, surgical intervention, hospitalization, discharge, and 1-year follow-up. The analysis will include consecutive medical records of patients operated on between January 2018 and February 2024.
- Conditions
- Peripheral Arterial Occlusive Disease, Critical Limb Ischemia, Arterial Revascularization, Arterial Bypass Surgery
- Being tested
- Graft dysfunction will be assessed through clinical examination and imaging follow-up to detect occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the treated limb.
- Keywords
- Peripheral arterial occlusive disease, critical limb ischemia, arterial revascularization, arterial bypass surgery
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graft dysfunction will be assessed through clinical examination and imaging follow-up to detect occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the treated limb.Procedure or surgery
This study concerns adult subjects with symptomatic lower limb arterial disease who have undergone arterial bypass surgery and are included in the study cohort. Graft dysfunction will be assessed through clinical examination and imaging follow-up to detect occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the treated limb.
| Study group | Role | What they receive |
|---|---|---|
| Arterial Bypass Cohort | The study group consists of adult patients with symptomatic lower limb arterial disease who have undergone arterial bypass surgery. Receives: Procedure: Graft dysfunction will be assessed through clinical examination and imaging follow-up to detect occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the treated limb. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the incidence of arterial bypass graft dysfunction, defined by the occurrence of at least one of the following events: occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the target limb.
The primary endpoint, graft dysfunction, will be evaluated through thorough clinical examinations combined with scheduled imaging assessments. These evaluations aim to identify any occurrence of occlusion, pseudoaneurysm formation, aneurysm rupture, infection, or major amputation of the treated limb. This comprehensive approach ensures early detection and accurate characterization of graft-related complications.
Measured: The primary outcome will be assessed at 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093632
- Sponsor's protocol ID
- 25-5202
- Acronym
- MERLLAB
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium-term Results of Lower Limb Arterial Bypass
- ClinicalTrials.gov ID
- NCT07093632
- Acronym / sponsor ID
- MERLLAB / 25-5202
- Conditions
- Peripheral Arterial Occlusive Disease, Critical Limb Ischemia, Arterial Revascularization, Arterial Bypass Surgery
- Keywords
- Peripheral arterial occlusive disease, critical limb ischemia, arterial revascularization, arterial bypass surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 30 Jul 2025 (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.
Peripheral arterial occlusive disease (PAOD) is a condition affecting the arteries of the lower limbs, caused by the progressive accumulation of lipid deposits that obstruct blood vessels. At an advanced stage, PAOD may progress to critical limb ischemia (CLI), characterized by persistent pain, chronic wounds, or gangrene. This situation constitutes a medical emergency, as it may result in limb loss or threaten the life of the patient.
In this context, arterial revascularization is essential to restore adequate blood flow to the tissues. Among therapeutic options, arterial bypass surgery remains a reference strategy. The choice of bypass type, the material used (autologous vein or prosthetic graft), perioperative conditions, and clinical characteristics of patients significantly influence the success of the intervention and both short- and long-term outcomes.
When an autologous vein is not available, the use of cold-stored allogeneic vein grafts has been proposed as an alternative. Several studies have evaluated their performance, showing encouraging results in terms of graft patency and limb salvage in patients with CLI. More recently, the REVATEC study confirmed these observations in a multicenter setting in France, highlighting the feasibility and safety of this technique in routine clinical practice].
Thus, a better understanding of the factors associated with the performance of arterial bypasses and the clinical evolution of patients in real-world practice is essential to optimize management strategies.
This retrospective study aims to analyze the clinical and technical data related to arterial bypass procedures performed in patients presenting with CLI. Data will be collected at various stages of the care pathway: preoperative phase, surgical intervention, hospitalization, discharge, and 1-year follow-up. The analysis will include consecutive medical records of patients operated on between January 2018 and February 2024.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arterial Bypass Cohort | – | Procedure: Graft dysfunction will be assessed through clinical examination and imaging follow-up to detect occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the treated limb.The study group consists of adult patients with symptomatic lower limb arterial disease who have undergone arterial bypass surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study concerns adult subjects with symptomatic lower limb arterial disease who have undergone arterial bypass surgery.
Key inclusion criteria (3 listed)
- Adults aged over 18 years
- Symptomatic lower limb arterial disease
- Undergoing revascularization bypass surgery
Key exclusion criteria (1 listed)
- Patients who have expressed opposition to the use of their data for research purposes
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 |
|---|---|---|
| Graft dysfunction will be assessed through clinical examination and imaging follow-up to detect occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the treated limb.This study concerns adult subjects with symptomatic lower limb arterial disease who have undergone arterial bypass surgery and are included in the study cohort. Graft dysfunction will be assessed through clinical examination and imaging follow-up to detect occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the treated limb. | Procedure or surgery | Arterial Bypass Cohort |
Primary outcome
The primary outcome is the incidence of arterial bypass graft dysfunction, defined by the occurrence of at least one of the following events: occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the target limb.
Time frame: The primary outcome will be assessed at 1-year follow-up
The primary endpoint, graft dysfunction, will be evaluated through thorough clinical examinations combined with scheduled imaging assessments. These evaluations aim to identify any occurrence of occlusion, pseudoaneurysm formation, aneurysm rupture, infection, or major amputation of the treated limb. This comprehensive approach ensures early detection and accurate characterization of graft-related complications.
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 30 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Occlusive Disease and Critical Limb Ischemia, run by Hospices Civils de Lyon 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 1 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 30 Jul 2025. 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?
The primary outcome is the incidence of arterial bypass graft dysfunction, defined by the occurrence of at least one of the following events: occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the target limb. (time frame: The primary outcome will be assessed at 1-year follow-up). 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 30 Jul 2025.