DRug-Eluting BallOOn Versus Primary Polymer-coated Paclitaxel Eluting STenting for Femoro-popliteal Lesions

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Feb 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for a condition called femoro-popliteal lesions, which are blockages in the blood vessels of the thigh and knee that can cause pain and difficulty walking. The trial compares a treatment using a special balloon that delivers medication (called a drug-eluting balloon) to a treatment using a stent coated with medication (called a polymer-coated paclitaxel-eluting stent). The main goal is to see if the balloon treatment works just as well as the stent treatment in keeping the blood vessels open for at least 12 months.

To participate in this study, individuals need to be at least 18 years old and have specific types of blockages in their blood vessels that meet certain criteria. They should not have any serious health issues that could affect their ability to participate. Participants can expect to undergo treatments and follow-up assessments at various times over two years to monitor their progress, including how well their blood vessels are functioning and how their quality of life is affected. It's important to know that this study is not yet recruiting participants, and the treatments will be closely monitored for safety and effectiveness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Target lesion is below the origin of the profunda femoris and does not exceed the medial femoral epicondyle.
• • Patent inflow artery (\<30% diameter stenosis).
• • Patency of at least one infrapopliteal artery to the ankle (\<30% diameter stenosis) in continuity with the native femoropopliteal artery.
• Exclusion Criteria:
• • Inability to obtain informed consent.
• • Life expectancy \<24 months.
• • Pregnancy or breastfeeding during study period.
• • Known clotting disorders.
• • Contraindication to antiplatelet therapy or anticoagulants.
• • Known hypersensitivity to nitinol or paclitaxel.
• • Enrollment into another study.
• • Significant iliac or common femoral stenosis (\<30% diameter) requiring intervention during the index procedure.
• • In-stent restenosis
• • Total occlusion non-crossable by a guidewire.
• • Acute thrombosis of target vessel
• • Prior ipsilateral femoro-popliteal bypass.
• • Implantation of a drug-eluting stent.