REBOOSTDrug-Eluting Balloon vs. Paclitaxel Eluting Stent for Femoro-popliteal Lesions
procedure of DCB implantation
+ procedure of SEDES implantation
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.402 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy 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
Department of Vascular Surgery, Ambroise Paré Hospital - AP-HP
Boulogne-Billancourt, FranceOpen Department of Vascular Surgery, Ambroise Paré Hospital - AP-HP in Google Maps