Lesion; FemoralPELI-CANNCT05216731
Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant
A study testing Femoro-popliteal bypass and Endovascular procedure in people with Lesion; Femoral, run by Assistance Publique - Hôpitaux de Paris at 16 sites in France.
Trial summary
In lower limb peripheral arterial disease, the stage of intermittent claudication has a prevalence of more than 5% over the age of 60, and affects patients who are often still active. Frequent anatomical lesions are strictures / occlusions of the superficial femoral artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lesion; Femoral
- What is being tested?
- Femoro-popliteal bypass and Endovascular procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 16 sitesFrance
- Study dates
- 20 Jan 2025to 20 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adult patient
- Effective contraception for the duration of research for fertile women of childbearing age
- Unilateral Rutherford 2 or 3 symptomatic Lower Extremity Artery Disease (LEAD) arteritic patient with a lesion of the superficial femoral artery Trans-Atlantic Inter-Society Consensus (TASC) C or D between 15 and 25 cm
- Patient eligible for bypass surgery and endovascular procedure
- No alteration of the upstream flow (iliac flow preserved or restored)
- Patient with at least one patent artery below the knee
- Patient informed and having signed the information and consent form to participate in the study
Who cannot join
- Known pregnancy or breastfeeding
- Iliac flow altered upstream
- History of surgery or stent on the affected superficial femoral artery
- Concomitant bacteremia (positive blood cultures in the 7 days preceding the procedure)
- Known intolerance to antiaggregants or heparin
- Contraindication to the endovascular procedure (severe renal failure contraindicating the injection of contrast product despite prior hydration, known severe allergy to iodinated contrast product [unless the center chooses to use carbon dioxide injection]) or bypass surgery (cardiovascular, respiratory or other comorbidities, contraindicating general anesthesia, local contraindications for bypass: skin lesion at the operative site)
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- No affiliation to a social security regime or to another social protection regime
- Patient deprived of liberty or under legal protection (guardianship, trusteeship)
- Inability, according to the investigator, to understand or refusal to sign the informed consent to participate in the study (non-French speaking patient, cognitive disorders)
- Ongoing participation in another research protocol Participation in non-interventional research is authorized
- Secondary exclusion criterion:
- Negative opinion from the anesthesiologist-resuscitator at the end of the pre-anesthetic consultation
- Positive pregnancy test from the pre-operative laboratory test (result received after obtaining consent, but before the surgical procedure)
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
France16 sites, 7 recruiting
- Active, not recruiting
CHU - Hôpitaux de Bordeaux
Bordeaux, 33 000
- Active, not recruiting
Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, 92 100
- Active, not recruiting
Hôpital de la Cavale Blanche
Brest, 29 200
- Active, not recruiting
Centre hospitalier René Dubos
Cergy-Pontoise, 95 300
- Recruiting
Hôpital Henri Mondor, APHP
Créteil, 94 010
Joseph TOUMA, Pr., +33 1.49.81.21.60 ext. +33, joseph.touma@aphp.fr
- Recruiting
Hôpital François Mitterrand
Dijon, 21 000
Eric STEINMETZ, Pr., 03.80.29.33.54 ext. +33, eric.steinmetz@chu-dijon.fr
- Active, not recruiting
Hôpital Edouard Herriot
Lyon, 69 003
- Not yet recruiting
Hôpital de la Timone, APHP
Marseille, 13 005
Marine GAUDRY, Dr., 04.91.38.80.92 ext. +33, marine.gaudry@ap-hm.fr
- Active, not recruiting
CHU de Nice
Nice, 06 001
- Not yet recruiting
CHU Carémeau
Nîmes, 30 029
Elsa FAURE, Dr., 04.66.68.39.30 ext. +33, elsa.faure@chu-nimes.fr
- Active, not recruiting
Hôpital Européen Georges Pompidou, APHP
Paris, 75 015
- Active, not recruiting
Hôpital Bichat - Claude Bernard, APHP
Paris, 75 018
- Not yet recruiting
Hôpital La Pitié-Salpêtrière, APHP
Paris, 75013
Thibault COUTURE, Dr., 01.42.17.58.08 ext. +33, thibault.couture@aphp.fr
- Recruiting
CHU de Poitiers
Poitiers, 86 000
Fabrice SCHNEIDER, Pr., 05.49.44.38.46 ext. +33, fabrice.schneider@chu-poitiers.fr
- Active, not recruiting
CHU de Rangueil
Toulouse, 31 400
- Not yet recruiting
Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu
Vandœuvre-lès-Nancy, 54 511
Nicla SETTEMBRE, Dr., 03.83.15.43.84 ext. +33, n.settembre@chru-nancy.fr
About this study
In lower limb peripheral arterial disease, the stage of intermittent claudication has a prevalence of more than 5% over the age of 60, and affects patients who are often still active. Frequent anatomical lesions are strictures / occlusions of the superficial femoral artery.
There is a current low level of evidence for the treatment modalities of long lesions (15-25 cm) of the superficial femoral artery and in particular no clinical trial comparing the femoro-popliteal bypass to the endovascular procedure whose patency in retrospective series. appears lower than that of surgery but nevertheless appears in the European recommendations for first-line treatment, with the absence of a dedicated trial being highlighted.
- Conditions
- Lesion; Femoral
- Being tested
- Femoro-popliteal bypass, Endovascular procedure
- Keywords
- Bypass, Endovascular procedure, Long lesions of the superficial femoral artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoro-popliteal bypassProcedure or surgery
Under general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis).
Endovascular procedureProcedure or surgery
Under general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty.
| Study group | Role | What they receive |
|---|---|---|
| Bypass group | Experimental | Under general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis). Receives: Procedure: Femoro-popliteal bypass |
| Endovascular procedure group | Active comparator | Under general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty. Receives: Procedure: Endovascular procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency rate at 2 year follow-up.
Primary patency is defined by the presence of satisfactory flow in the superior femoral artery or bypass
Measured: 2 year
Secondary outcomes (8)
Primary patency rate at 1 year follow-up.
Primary patency is defined by the presence of satisfactory flow in the superior femoral artery or bypass
Measured: 1 year
Secondary patency rate at 1 and 2 years follow-up.
Secondary patency is defined as the patency after treatment of a (re)occlusion of the index lesion or bypass.
Measured: 1 and 2 years
Clinical improvement according to the Rutherford classification (clinical stages of ischemia) at 1, 6, 12 and 24 months
Clinical improvement is considered as an improvement in the Rutherford stage, i.e. a downshift to Rutherford 0 or 1.
Measured: 1, 6, 12 and 24 months
Improvement of the walking perimeter at 1 and 2 years (<200m,> 200m, unlimited)
Improvement of the walking perimeter is related to Rutherford stage. It is assessed by questioning the patient about the ability to have an unlimited walking distance, or moderately limited (> 200m), or severely limited (<200m).
Measured: 1 and 2 years
The increase in the systolic pressure index at discharge from hospital, then at 1, 6, 12 and 24 months (<0.75,> 0.75)
The increase of the systolic pressure index (SPI) is obtained by comparing all post-operative measures to pre-operative values.
Measured: 1, 6, 12 and 24 months
The quality of life measured by the Vascu-Qol 6 to 2 years
The quality of life assessment is obtained by filling the Vascu-Qol questionnaire and comparing the score with the preoperative value.
Measured: 2 years
The treatment burden measured by the Treatment Burden Questionnaire at 6 months
The treatment burden is evaluated by comparing the Treatment Burden Questionnaire score at 6 months with the preoperative value.
Measured: 6 months
Number of participants with adverse events as assessed by hematoma, redo surgery or vascular infection at 2 years
Tolerance is assessed by looking for the following events during the two postoperative years: hematoma that necessitated hospital stay, vascular infection, or redo surgery because of vascular complication.
Measured: During 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start20 Jan 2025
- Primary completion7 Mar 2030 (estimated)
- Study completion20 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lesion; FemoralStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph TOUMA, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216731
- Sponsor's protocol ID
- APHP191106
- Acronym
- PELI-CAN
- Status last verified
- Sep 2025
- First submitted
- 24 Jan 2022
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant
- ClinicalTrials.gov ID
- NCT05216731
- Acronym / sponsor ID
- PELI-CAN / APHP191106
- Conditions
- Lesion; Femoral
- Keywords
- Bypass, Endovascular procedure, Long lesions of the superficial femoral artery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 7 Mar 2030 (estimated)
- Study completion
- 20 May 2030 (estimated)
- First posted
- 31 Jan 2022 (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.
In lower limb peripheral arterial disease, the stage of intermittent claudication has a prevalence of more than 5% over the age of 60, and affects patients who are often still active. Frequent anatomical lesions are strictures / occlusions of the superficial femoral artery.
There is a current low level of evidence for the treatment modalities of long lesions (15-25 cm) of the superficial femoral artery and in particular no clinical trial comparing the femoro-popliteal bypass to the endovascular procedure whose patency in retrospective series. appears lower than that of surgery but nevertheless appears in the European recommendations for first-line treatment, with the absence of a dedicated trial being highlighted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bypass group | Experimental | Procedure: Femoro-popliteal bypassUnder general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis). |
| Endovascular procedure group | Active comparator | Procedure: Endovascular procedureUnder general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patient
- Effective contraception for the duration of research for fertile women of childbearing age
- Unilateral Rutherford 2 or 3 symptomatic Lower Extremity Artery Disease (LEAD) arteritic patient with a lesion of the superficial femoral artery Trans-Atlantic Inter-Society Consensus (TASC) C or D between 15 and 25 cm
- Patient eligible for bypass surgery and endovascular procedure
- No alteration of the upstream flow (iliac flow preserved or restored)
Key exclusion criteria (13 listed)
- Known pregnancy or breastfeeding
- Iliac flow altered upstream
- History of surgery or stent on the affected superficial femoral artery
- Concomitant bacteremia (positive blood cultures in the 7 days preceding the procedure)
- Known intolerance to antiaggregants or heparin
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 |
|---|---|---|
| Femoro-popliteal bypassUnder general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis). | Procedure or surgery | Bypass group |
| Endovascular procedureUnder general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty. | Procedure or surgery | Endovascular procedure group |
Primary outcome
Primary patency rate at 2 year follow-up.
Time frame: 2 year
Primary patency is defined by the presence of satisfactory flow in the superior femoral artery or bypass
8 secondary outcomes
Primary patency rate at 1 year follow-up.
Time frame: 1 year
Secondary patency rate at 1 and 2 years follow-up.
Time frame: 1 and 2 years
Clinical improvement according to the Rutherford classification (clinical stages of ischemia) at 1, 6, 12 and 24 months
Time frame: 1, 6, 12 and 24 months
Improvement of the walking perimeter at 1 and 2 years (<200m,> 200m, unlimited)
Time frame: 1 and 2 years
The increase in the systolic pressure index at discharge from hospital, then at 1, 6, 12 and 24 months (<0.75,> 0.75)
Time frame: 1, 6, 12 and 24 months
The quality of life measured by the Vascu-Qol 6 to 2 years
Time frame: 2 years
The treatment burden measured by the Treatment Burden Questionnaire at 6 months
Time frame: 6 months
Number of participants with adverse events as assessed by hematoma, redo surgery or vascular infection at 2 years
Time frame: During 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 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.
Joseph TOUMA, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoro-popliteal bypass and Endovascular procedure in people with Lesion; Femoral, run by Assistance Publique - Hôpitaux de Paris at 16 sites 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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph TOUMA, MD, PhD (+ 33 6 30 03 10 93 ext. + 33, joseph.touma@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency rate at 2 year follow-up. (time frame: 2 year). 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 3 Oct 2025.