A Newly Designed Nitinol Stent: Early Clinical Experience in the Treatment of Iliac Artery Stenoses and Occlusions

ABSTRACT

OBJECTIVE: To investigate the effectiveness of the newly designed Niti-S stent in the management of iliac arterial stenoses and occlusions. MATERIALS AND METHODS: Stenoses (n=25) or occlusions (n=5) in the iliac arteries of 25 patients (30 limbs) were treated. The site of the lesions was the common (n=15) or external (n=11) iliac artery, or both (n=4). Eight limbs were treated for diffuse disease, six for highly eccentric lesion, five for occlusive lesion, and 11 for failed angioplasty. RESULTS: In all patients, technical success was achieved without major complications. One death, not procedure-related, occurred within 30 days. Ankle-brachial indexes improved from 0.63 +/- 0.30 to 0.99 +/- 0.21, and ischemic symptoms showed improvement in 22 patients (88%). Fontaine classifications before stenting, namely IIa(n=3), IIb(n=16), III(n=2), and IV(n=4) improved to I(n=17), IIa(n=5), and IV(n=3). Follow-up over a 27 (mean, 19.8 +/- 8)-month period showed that cumulative patency rates were 95.8% at 1 year and 86.2% at 2 and 3 years. No significant decrease in the mean ankle-brachial index was observed. CONCLUSION: The Niti-S stent appears to be a safe and effective device for the treatment of iliac stenoses and occlusions. These preliminary results require confirmation with a larger series.