LAUSR

BACKGROUND Endovascular treatment has become the first-line revascularisation technique for femoropopliteal lesions. This technique lacks of reliable and accurate morphological control of the arterial segment treated. Intraoperative 2-D angiogram consumes iodinated contrast media and increases X-ray exposure; this subsequently provides none 3D information on the quality of the revascularisation completed, what could explain some of the early and late failures of the technique. AIM Our objective is to evaluate if intra-operative optical coherence tomography (OCT) control in addition to standard angiogram could improve the primary patency rate at 12 months in comparison to standard angiogram alone in patients with occlusive femoropopliteal lesions. METHOD the ToCaf trial is a multicentric, prospective, randomised, controlled, single-blind study including patients with long de novo occlusive femoropopliteal lesions. The randomisation will be achieved in 2 balanced groups of patients after crossing successfully the lesion: group 1 with intra-operative OCT control in addition to standard angiogram and group 2 with standard angiogram alone. The randomisation will be stratified by centre. The protocol has been submitted and approved by a French ethic's committee under ref CPP2019-12-098. The study has been registered under the reference NCT04434586on the clinicaltrials.gouv's website. RESULTS The primary outcome of the study is the primary patency at 12 months. The number of patients that need to be treated is 166 (83 in each group) considering 5% of not workable data. Symptoms' improvement, target lesion revascularisation, target vessel revascularisation, quality of life questionnaires, cost-utility and cost-effectiveness will be analysed as secondary endpoint variables at 12 months. CONCLUSION The aim of the present study is to evaluate the potential benefit for patients on the result of endovascular revascularisation of long occlusive femoro-popliteal lesion at 12-month when using intraoperative OCT control .