Objective: To investigate the effectiveness of the newly designed Niti-S st
ent in the management of iliac arterial stenoses and occlusions.
Materials and Methods: Stenoses (n=25) or occlusions (n=5) in the iliac art
eries of 25 patients (30 limbs) were treated, The site of the lesions was t
he common (n=15) or external (n=11) iliac artery, or both (n=4). Eight limb
s were treated for diffuse disease, six for highly eccentric lesion, five f
or occlusive lesion, and 11 for failed angioplasty.
Results: In all patients, technical success was achieved without major comp
lications. One death, not procedure-related, occurred within 30 days. Ankle
-brachial indexes improved from 0.63 +/- 0.30 to 0.99 +/- 0.21, and ischemi
c symptoms showed improvement in 22 patients (88%). Fontaine classification
s before stenting, namely IIa(n=3), IIb(n=16), III(n=2), and IV(n=4) improv
ed 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 r
equire confirmation with a larger series.