DRug-Eluting BallOOn Versus Primary Polymer-coated Paclitaxel Eluting STenting for Femoro-popliteal Lesions
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- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT06835660
- Record updated
- 19 February 2025
- Original description
Main objective of the study: To demonstrate that a primary DCB strategy is non-inferior in terms of primary patency to a primary SEDES strategy for above-the-knee femoro-popliteal lesions at 12 months.Read full original descriptionShow less
Main objective of the study: To demonstrate that a primary DCB strategy is non-inferior in terms of primary patency to a primary SEDES strategy for above-the-knee femoro-popliteal lesions at 12 months.
Primary endpoint: Freedom from loss of primary patency at 12 months: loss of primary patency will be defined as the need for target vessel revascularization and/or binary restenosis (defined as >70% in diameter or peak systolic velocity >2.4 m/sec at duplex examination).
Secondary objectives:
To demonstrate that a primary DCB strategy is non-inferior to a primary SEDES strategy in terms of:
* Intra-operative technical success. * Safety at 1, 6, 12, 18 and 24 months. * Primary patency at 1, 6, 12, 18 and 24 months. * Assisted primary patency at 1, 6, 12, 18 and 24 months. * Secondary patency at 1, 6, 12, 18 and 24 months. * All target vessel revascularization at 1, 6, 12, 18 and 24 months. * Clinically-driven target vessel revascularization at 1, 6, 12, 18 and 24 months. * All TLR at 1, 6, 12, 18 and 24 months. * Clinically-driven TLR at 1, 6, 12, 18 and 24 months. * All target extremity revascularization at 1, 6, 12, 18 and 24 months. * Number of secondary interventions at 1, 6, 12, 18 and 24 months. * Binary restenosis at 1, 6, 12, 18 and 24 months. * Mean Rutherford category at 1, 6, 12, 18 and 24 months. * Mean ABI value at 1, 6, 12, 18 and 24 months. * Absolute claudication distance improvement at 1, 6, 12, 18 and 24 months. * Quality of life at 1, 6, 12, 18 and 24 months. * Cost at 1, 6, 12, 18 and 24 months.
Inclusion: 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: Contraindication to antiplatelet therapy or anticoagulants; Prior ipsilateral femoro-popliteal bypass; Implantation of a drug-eluting stent; Known clotting disorders; Known hypersensitivity to nitinol or paclitaxel; Acute thrombosis of target vessel; Inability to obtain informed consent; Life expectancy <24 months; Pregnancy or breastfeeding during study period; 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.