Introduction: The population of patients with lower limb atherosclerosis includes a considerable proportion of individuals with long superficial femoral artery (SFA) lesions. Chronic total occlusions (CTOs) represent the "last frontier" of percutaneous interventions. While open strategies are considered earlier as standard management for these lesions, the results of a number of trials indicate that endovascular management might become an effective alternative to surgery. Material and methods: This paper presents 5-year outcomes of a first-in-man (FIM) study (before CE mark) and the registry of OCT Guided Ocelot Catheter (Avinger) for chronic total occlusions of the superficial femoral artery. The study group comprised 10 patients with Rutherford 3 lower limb ischemia including nine men and one woman. Results: The efficacy of the primary intervention was 90%. Angiography performed at 6 months of the procedure, according to the study protocol, revealed 3 and 1 cases of restenosis and reocclusion, respectively, repaired using PTA and open common and deep femoral artery patch plasty. Doppler ultrasound performed at 1, 2 and 5 years after the primary intervention did not reveal significant target vessel restenosis. The primary and primary-assisted patency was 89%. During a 5-year follow-up, four peripheral percutaneous interventions and one femoropopliteal bypass surgery were performed in non-target limbs. There were no cardiovascular deaths, myocardial infarction or stroke and no amputation was required. Conclusions: This is a first-in-man study reporting long-term follow-up after SFA CTO revascularization using the Ocelot catheter. The catheter proved to have a satisfactory safety profile and a high proportion of CTO crossings. A 5-year follow-up revealed high primary and primary-assisted patency rates.
- Optical coherence tomography
- Superficial femoral artery occlusion
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine