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Leg artery showdown: bypass vs. balloon for blockages

NCT ID NCT05216731

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two treatments for long blockages (15-25 cm) in the leg's main artery. One is bypass surgery, which uses a vein or artificial tube to reroute blood flow. The other is a less invasive procedure using a balloon to open the artery, often with a stent. The trial will enroll 290 adults with leg pain when walking (claudication) to see which treatment keeps the artery open longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If this trial succeeds, it could show which treatment (bypass surgery or a less invasive procedure) works better for keeping leg arteries open in people with long blockages.
What could go wrong
This is a mid-stage trial with 290 people, so results may not apply to everyone. Both procedures have risks like infection, bleeding, or the artery re-blocking.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 290 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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)

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Conditions

The condition(s) this trial relates to.

femoral neuropathy peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lesion; femoral

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU - Hôpitaux de Bordeaux

    ACTIVE_NOT_RECRUITING

    Bordeaux, 33 000, France

  • CHU Carémeau

    NOT_YET_RECRUITING

    Nîmes, 30 029, France

  • CHU de Nice

    ACTIVE_NOT_RECRUITING

    Nice, 06 001, France

  • CHU de Poitiers

    RECRUITING

    Poitiers, 86 000, France

  • CHU de Rangueil

    ACTIVE_NOT_RECRUITING

    Toulouse, 31 400, France

  • Centre hospitalier René Dubos

    ACTIVE_NOT_RECRUITING

    Cergy-Pontoise, 95 300, France

  • Hôpital Ambroise Paré, APHP

    ACTIVE_NOT_RECRUITING

    Boulogne-Billancourt, 92 100, France

  • Hôpital Bichat - Claude Bernard, APHP

    ACTIVE_NOT_RECRUITING

    Paris, 75 018, France

  • Hôpital Edouard Herriot

    ACTIVE_NOT_RECRUITING

    Lyon, 69 003, France

  • Hôpital Européen Georges Pompidou, APHP

    ACTIVE_NOT_RECRUITING

    Paris, 75 015, France

  • Hôpital François Mitterrand

    RECRUITING

    Dijon, 21 000, France

  • Hôpital Henri Mondor, APHP

    RECRUITING

    Créteil, 94 010, France

  • Hôpital La Pitié-Salpêtrière, APHP

    NOT_YET_RECRUITING

    Paris, 75013, France

  • Hôpital de la Cavale Blanche

    ACTIVE_NOT_RECRUITING

    Brest, 29 200, France

  • Hôpital de la Timone, APHP

    NOT_YET_RECRUITING

    Marseille, 13 005, France

  • Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu

    NOT_YET_RECRUITING

    Vandœuvre-lès-Nancy, 54 511, France