The Perflex stent, a novel balloon-expandable vascular stent:: Preliminary clinical results.

Purpose: Clinical evaluation of a newly developed balloon-expandable vascular stent. Method: Participating in a multi-center study our clinic enrolled 12 patients with 15 iliac artery stenoses (Fontaine IIa-III) that were treated with the new stent. Three patients had bilateral stenoses. The mean ankle-brachial index (ABI) at rest was 0.76 +/- 0.25 (+/- 1 standard deviation), the mean ABI after exercise was 0.47 +/- 0.20. Indication for stent insertion was a residual trans-lesion pressure gradient greater than or equal to 10 mmHg after balloon angioplasty. Follow-up included clinical examination, measurements of the ABI at rest and after exercise, and colour duplex ultrasound (CDS) on the day of hospital dismissal and 1, 6 and 12 months after stent insertion. Results: 16 stents were placed successfully. One stenosis was treated with two stents. Acute complications did not occur. The Fontaine stage increased by at least one stage in all patients. The ABI at rest rose to 0.91 +/- 0.26, the ABI after exercise to 0.86 +/- 0.29. During followup one stent occlusion, one stenosis proximal to a stent, and CDS-findings suggesting restenosis in two further stents were observed. Conclusions: it appears that the Perflex stent may be used in the iliac arteries with a success rate similar to other stents. However, this preliminary result has to be confirmed in a larger series and after a longer follow-up.