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

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.