402
Participants
Start Date
May 31, 2025
Primary Completion Date
November 30, 2028
Study Completion Date
December 31, 2028
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%."
Department of Vascular Surgery, Ambroise Paré Hospital - AP-HP, Boulogne-Billancourt
Assistance Publique - Hôpitaux de Paris
OTHER