The 12 and 24 Months Results of the VMI-CFA Study, a Physician-Initiated Trial Investigating the Efficacy of the Vascular Mimetic Implant Supera Peripheral Stent System for the Treatment of the Common Femoral Artery

OBJECTIVE: The objective of the Vascular Mimetic Implant-Common Femoral Artery Study (VMI-CFA) investigation is to evaluate the mid-term (24 months) outcome of treatment of the common femoral artery (CFA) with the Supera Peripheral Stent System (Abbott Vascular Inc., Santa Clara, USA) in symptomatic (Rutherford 2-4), de novo stenotic or occlusive lesions. METHODS: One hundred patients with atherosclerotic lesions in the CFA were recruited for the VMI-CFA trial during routine consultations in hospitals in Belgium and France. The key inclusion criterion was de novo, stenotic (>50%) or occlusive lesions located in the native CFA. The main exclusion criteria were asymptomatic disease, (in-stent) restenosis and occlusion of the deep femoral artery. The primary efficacy and safety endpoint were defined respectively as primary patency at 12 months core lab adjudicated and any periprocedural adverse events up to 30 days post-procedure. The secondary endpoints included technical success rate, primary patency at 1, 6 and 24 months post-procedure, freedom from target lesion revascularization (TLR) at 1, 6, 12 and 24 months post-procedure and clinical success. RESULTS: The Supera Stent was deployed and implanted successfully in all 100 patients. At 12 and 24 months, the primary patency rate was 95.2% and 92.8%, respectively. Two patients had to undergo a TLR between 6 and 12 months of follow-up, which resulted in a freedom from TLR rate of 97.8%. This rate remained the same at 24-month follow-up. Regarding the primary safety endpoint, there were 17 periprocedural adverse events in the first month after the index procedure, but no device- or procedure-related deaths, TLRs, major target limb amputations or thromboses were reported. Survival rate at 12 months was 91.8%. At 1, 6 and 24 months of follow-up, the survival rate was 100%, 96.9% and 85.5%, respectively. Fourteen patients died during the 2-year follow-up period. None of the deaths was procedure- or study-device related. A clear shift from Rutherford classification 2 to 4 toward 0 to 1 was seen and displays the clinical success of the endovascular therapy with the Supera Peripheral Stent System. CONCLUSION: The VMI-CFA trial shows that endovascular treatment of the "no-stent zone" CFA atherosclerotic disease with the Supera Peripheral Stent System is a safe and efficient therapy in CFA treatment.Clinical ImpactThis study provides prospective evidence supporting Supera stenting for common femoral artery disease, traditionally treated by open endarterectomy. The encouraging patency and safety outcomes suggest a minimally invasive alternative for selected patients, particularly those with hostile groin anatomy or increased risk of wound complications. By specifically evaluating an interwoven nitinol stent in this challenging arterial territory, these findings may help clinicians individualize revascularization strategies. However, the nonrandomized design does not establish superiority over endarterectomy. Randomized comparative evidence is needed before broader adoption or changes to the current standard of care.