Stent placement in the superficial femoral and proximal popliteal arteries with the innova self-expanding bare metal stent system.

OBJECTIVES: The SuperNOVA trial was designed to evaluate performance of the Innova Vascular Self-Expanding Stent System (Boston Scientific, Marlborough, MA) for treating lesions in the femoropopliteal arteries. METHODS: Patients with chronic lower limb peripheral artery disease (Rutherford category 2, 3, or 4) and atherosclerotic lesions in the native superficial femoral and/or proximal popliteal artery (lengths 30-190 mm) were enrolled in this single-arm, multinational study. Major adverse events (MAEs) were defined as all-cause death through 1 month, target limb major amputation, and target lesion revascularization (TLR). Vessel primary patency was defined as core laboratory-adjudicated duplex ultrasonography-derived peak systolic velocity ratio ≤2.4 in the absence of TLR, surgical bypass of the target lesion, or major amputation of the target limb. Primary safety and efficacy endpoints were evaluated at 12 months, with follow-up through 24 months also reported. RESULTS: SuperNOVA patients (N = 299; mean age 67.4 ± 9.7 years, 74% men, 41% with diabetes) had a mean lesion length of 93.2 mm. The MAE-free rate was 99.7% at 30 days, 85.8% at 12 months, and 77% at 24 months. Kaplan-Meier estimates of primary patency and TLR-free rates were 68.7% and 78.0%, respectively, at 24 months. Clinical improvements were sustained through 2 years, with 80% of patients displaying no or minimal symptoms (Rutherford category 0-1) at 24 months. CONCLUSIONS: In the SuperNOVA study, the Innova Stent System demonstrated an excellent safety profile and acceptable clinical outcomes despite the challenging anatomical characteristics of the lesions. © 2017 Wiley Periodicals, Inc.