Abstract
The purpose of this study was to evaluate the safety and efficacy of self-expanding SMART nitinol stents in patients with chronic limb ischemia (CLI) demonstrating Type B or C TransAtlantic Inter-Society Consensus (TASC) lesions in the femoropopliteal (FP) arterial segment. There were 137 lower limbs in 122 patients with chronic limb ischemia, secondary to TASC A (n = 12) or TASC B,C (n = 125) lesions in the FP artery were treated with Cordis SMART self-expanding nitinol stents. Hemodynamic stent failure occurred with the presence of a greater than 50% stenosis within the stented segment, measured by standard Duplex velocity criteria, obtained at various postintervention intervals. The hemodynamic primary stent patency was calculated by life-table methods from the time of intervention, uninterrupted by hemodynamic stent failure. The mean lesion length was 12.2 cm (range, 4 to 28 cm). The technical success was 98%. Within the follow-up period (mean, 302 days), 24 limbs were diagnosed with hemodynamic stent failure. The hemodynamic primary stent patency rates were 92%, 76%, 66%, and 60% at 6, 12, 18, and 24-months, respectively. These data provide objective evidence that endovascular treatment of FP TASC A, B and C lesions using self-expanding nitinol SMART stents in patients with chronic limb ischemia provides favorable safety and durability outcomes. Further investigation is warranted.
Published Version
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