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Clinical Trials in France / NCT06835660
Starting soon Not applicable

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

NCT06835660 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2025-05
Last updated
2025-02-19

Condition(s) studied

Femoropopliteal Lesion

Investigational drug(s) / intervention(s)

procedure of DCB implantationprocedure of SEDES implantation

procedure of DCB implantation: 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 (120 seconds inflation minimum). One or several DCBs will be inflated at the level of the lesions depending on lesions' lengths. The DCB diameter(s) will be the one(s) of the index diameter of the artery. Overlaps between zones that will receive DCB inflations will be of 10 mm to avoid any geographic miss.

procedure of SEDES implantation: SEDES implantation wille be performed according to the SEDES instructions for use. Stent(s) oversizing will be of 1 mm maximum. Overlaps between stents will be of 10 mm. Completion angiogram will assess the technical success of the procedure (see endpoints definitions). The physician may then decide to add a bailout SEBMS because of flow limiting dissection and/or a new stenosis \>30%.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Loss of primary patency — at 12 months
    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

Trial sites (1)

FacilityCityRegionStatus
Department of Vascular Surgery, Ambroise Paré Hospital - AP-HP Boulogne-Billancourt France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06835660 on ClinicalTrials.gov ↗ ← All trials in France