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

NANot yet recruitingINTERVENTIONAL
Enrollment

402

Participants

Timeline

Start Date

May 31, 2025

Primary Completion Date

November 30, 2028

Study Completion Date

December 31, 2028

Conditions
Femoropopliteal Lesion
Interventions
DEVICE

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.

DEVICE

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%."

Trial Locations (1)

92100

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

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT06835660 - DRug-Eluting BallOOn Versus Primary Polymer-coated Paclitaxel Eluting STenting for Femoro-popliteal Lesions | Biotech Hunter | Biotech Hunter