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Stents vs scalpels: testing a less invasive fix for blocked leg arteries

NCT ID NCT01353651

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers compare two ways to restore blood flow in the common femoral artery, a vessel in the upper leg. One group receives a self-expandable nitinol stent placed inside the artery, and the other has open surgery. The trial enrolls 120 adults with narrowed or blocked arteries causing leg symptoms. It measures complications and deaths within 30 days, along with technical success, hospital stay, and long-term symptom relief.

What this could mean

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

Active substance
self-expandable nitinol stents placed inside the artery
What this could lead to
If stenting works as well as surgery, people with blocked leg arteries could recover faster and avoid a larger operation.
What could go wrong
Stents can narrow again over time and may need another procedure. This trial is small and only includes people with a specific type of artery blockage, so results may not apply to everyone.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

120 people

The number who actually took part.

Start date

Feb 2011

Finished

Sep 2015

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

40 to 90 years

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: * Age between 40 and 90 years-old * De novo atheromatous common femoral artery stenosis * Symptomatic lesions (Rutherford stages 3, 4, 5 and 6) * Haemodynamically significant lesion * Written informed consent Exclusion Criteria: * Restenosis * Non-atheromatous lesions (dysplasia, post-traumatic, inflammatory) * external iliac thrombosis and / or common femoral side to treat * Contraindication to open surgery or endovascular treatment * Contraindication to anesthesia * Indication of aorto-femoral, ilio-femoral, femoral-popliteal or femoro-tibialis bypass to associate with the common femoral revascularization * Indication of a surgical approach to the external iliac artery through a retroperitoneal * Asymptomatic lesions * Life expectancy less than one year * Refusing patient * Inability to monitor during the test period * Participation in another clinical trial * Pregnant Women * No written informed consent

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As listed by the trial registrant

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

Atherosclerotic lesions of the common femoral artery

Contacts and locations

Locations

  • NCN Clinic

    Nantes, France

  • St Augustin Clinic

    Nantes, France

  • Tonkin Clinic

    Villeurbanne, France

  • University Hospital

    Amiens, France

  • University Hospital

    Besançon, France

  • University Hospital

    Bordeaux, France

  • University Hospital

    Clermont-Ferrand, France

  • University Hospital

    Dijon, France

  • University Hospital

    Lyon, France

  • University Hospital

    Marseille, France

  • University Hospital

    Nantes, France

  • University Hospital

    Nice, France

  • University Hospital

    Rouen, France

  • University Hospital

    Saint-Etienne, France

  • University Hospital

    Strasbourg, France

  • University Hospital, HEGP

    Paris, France

  • University Hospital, Henri Mondor

    Paris, France