New balloon and laser combo may save legs and money
NCT ID NCT02599389
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tested three ways to treat leg arteries that have reblocked after stent placement: standard balloon angioplasty, a drug-coated balloon, and a laser plus drug-coated balloon. The goal was to see which approach is most cost-effective over 18 months. The trial involved 222 adults with symptoms like leg pain or poor circulation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- drug-coated balloon (paclitaxel) and excimer laser
- What this could lead to
- If successful, this could identify a more cost-effective way to treat reblocked stents in leg arteries, potentially improving blood flow and reducing the need for repeat procedures.
- What could go wrong
- This is a completed phase 3 trial, but the results may not apply to all patients. The treatments carry risks like vessel damage or recurrence of blockage, and the cost benefits may vary.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 222 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2015
- Finished
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May 2020
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Patient of age \> 18 years * Patient with previously peripheral implanted stent(s) located in or extending to the popliteal artery * Patient who received this stent between 3-36 months before inclusion * Patient with one or more in-stent restenosis lesion(s) \> 70% in the same arterial segment in association with clinical symptoms of claudication or an critical limb ischemia with Rutherford classification of 2, 3, 4 or 5 * Reference vessel diameter between 4 and 7 mm * Patient affiliated to a social security regimen * EC-approved consent form signed by the participant and the investigator (must be signed prior initiation of any study related intervention) Exclusion Criteria: * Life expectancy \>18 months * Patient already included in this study (recruitment of the contralateral leg is not allowed) * Patient contraindicated for the use of antiplatelet therapy * Pregnant or breast-feeding women * Patient with a target limb infection being treated * Patient with a procoagulant blood disease * Patient with history of contrast agents allergies * Patient with intolerance to paclitaxel * Patient with severe renal impairment (GFR \<30 ml / min / 1.73 m²) or patient with a creatinine clearance \<15 ml / min * External compression of previously implanted stent * Patient participating in any clinical trial using another investigational drug or product which could interfere with the interpretation of the trial results. * Patient under trusteeship or guardianship Angiographic exclusion criteria : * Inflow (above) severe lesion \>70% or occlusion untreated satisfactorily (residual lesion\> 50%) before the management of the target lesion * Perforation, dissection or lesions on the arterial network access requiring an assumption prior to randomization * Stent fracture grade 4 or 5 at the target lesion
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Hospitalier Universitaire de Besançon
Besançon, 25030, France
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Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63000, France
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Centre Hospitalier Universitaire de Dijon
Dijon, 21079, France
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Centre Hospitalier Universitaire de Nantes
Nantes, 44093, France
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Centre Hospitalier Universitaire de St Etienne
Saint-Etienne, 42055, France
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Centre Hospitalier Universitaire de Strasbourg
Strasbourg, 67091, France
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Clinique Pasteur
Toulouse, 31076, France
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Clinique Rhône Durance
Avignon, 84000, France
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Clinique de L'Europe
Rouen, 76100, France
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Hospices Civils de Lyon
Lyon, 69000, France
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Hôpital Européen Georges Pompidou - AP-HP de Paris
Paris, 75015, France
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Polyclinique Les Fleurs
Ollioules, 83190, France
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University Hospital of Bordeaux - Hospital Pellegrin
Bordeaux, 33000, France
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