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REBOOSTDrug-Eluting Balloon vs. Paclitaxel Eluting Stent for Femoro-popliteal Lesions

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What is being tested

procedure of DCB implantation

+ procedure of SEDES implantation

Device
Who is being recruted

Over 18 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2025
See protocol details

Summary

Principal SponsorAssistance Publique - Hôpitaux de Paris
Study ContactRaphaël COSCAS, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on comparing two different treatments for blockages in the arteries of the legs, specifically in the femoropopliteal region. These blockages are common in those with peripheral artery disease, affecting blood flow to the lower limbs. The study compares drug-eluting balloons (DCB) and self-expandable polymer-coated paclitaxel eluting stents (SEDES) as treatment options. Both methods have shown benefits in previous research, but there is still uncertainty about which is better. The goal is to determine which treatment is more effective and safer, which could lead to better care for patients with these artery blockages. Participants in the study will undergo a procedure where a small tube is inserted into the femoral artery to examine and treat the blockage. Initially, a balloon is used to open the artery, and if successful, patients will be randomly assigned to receive either the DCB or SEDES treatment. The study will involve careful monitoring at various intervals over two years to assess the effectiveness and safety of the treatments. Participants will take medication to prevent blood clots during and after the study. The results will help determine which treatment better maintains blood flow in the arteries without complications.

Official TitleDRug-Eluting BallOOn Versus Primary Polymer-coated Paclitaxel Eluting STenting for Femoro-popliteal Lesions
NCT06835660
Principal SponsorAssistance Publique - Hôpitaux de Paris
Study ContactRaphaël COSCAS, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

402 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate
Subject age ≥ 18

Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.

Rutherford category 2-4.

Femoro-popliteal stenosis/occlusion

Show More Criteria

13 exclusion criteria prevent from participating
Inability to obtain informed consent.

Life expectancy <24 months.

Pregnancy or breastfeeding during study period.

Known clotting disorders.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Drug coated balloon(s) will be used for femoropopliteal lesions. Patients assigned to the DCB group (study group) will receive DCB inflation(s) at the level of the lesions according the DCB instructions for use.

Group II

Active Comparator
Uncovered self-expandable polymer coated paclitaxel eluting stent(s) will be used for femoropopliteal lesions. Patients assigned to the SEDES group (control group) will receive implantation ELUVIA stents at the level of the lesion(s) according to the SEDES instructions for use.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Vascular Surgery, Ambroise Paré Hospital - AP-HP

Boulogne-Billancourt, FranceOpen Department of Vascular Surgery, Ambroise Paré Hospital - AP-HP in Google Maps
Recruiting soonOne Study Center