Clinical Experience with a New Nitinol Self-Expanding Stent in Peripheral Arteries

Abstract

Purpose: To evaluate a new self-expanding nitinol coil stent in stenotic or occluded peripheral arteries. Methods: Seventy-three symptomatic patients (58 men; mean age 67 years) were treated with nitinol stents for lesions in the iliac artery (9 stenoses); superficial femoral artery (SFA) (39 stenoses, 6 occlusions); popliteal artery and tibioperoneal trunk (9 stenoses, 7 occlusions); and 3 bypass grafts. Mean diameter stenosis was 84.4% ± 9.9% (range 75% to 100%), and mean lesion length was 45 ± 23 mm (range 20 to 120 mm). Results: Eighty-eight 40-mm-long stents with diameters between 5 and 8 mm were implanted percutaneously for suboptimal dilation (n = 45); dissection (n = 21); and restenosis (n = 7). All stents but one were implanted successfully; the malpositioned stent was removed, and another stent was successfully deployed. There were 3 (4.1%) failures due to thrombosis at 24 hours. During the mean 16-month follow-up (range to 44 months), 4 restenoses (3 femoral, 1 popliteal) have occurred; 2 were treated with repeat dilation and 2 underwent bypass. Primary and secondary patency rates at 18 months were 87% and 90%, respectively, for all lesions (iliac: 100% for both; femoral: 85% and 88%; popliteal: 87% and 100%). Conclusions: This new nitinol stent seems to be safe and effective with favorable long-term results, even in distal SFA lesions and popliteal arteries. Its flexibility and resistance to external compression allow its placement in tortuous arteries and near joints.

Short- and long-term histopathologic evaluation of stenting using a self-expanding nitinol stent in pig carotid and iliac arteries

“…In addition, current stents made of stainless steel or other ferrous metals create artifacts under CT or MRI, limiting the capacity for noninvasive assessment. Nitinol is being increasingly used in vascular stenting [23,24]. The Endostent, due to its composition and design, may be able to solve each of the above-mentioned stent limitations.…”

Endovascular stent implantation for treatment of peripheral artery disease

“…2). Initial reports of stenting in the superficial femoral artery showed promising results with primary and secondary patency rates of 87-90% at 18 months [18]. However, subsequent studies demonstrated that exaggerated neo-intimal hyperplasia in the stented segment frequently leads to instent-restenosis and five randomized controlled trials failed to demonstrate a beneficial effect of SFA stenting using stainless-steel stents compared to plain balloon angioplasty [4,[19][20][21][22].…”

Fatigue and durability of Nitinol stents

“…Clinical outcomes are assessed at various (Duda et al, 2002;Sabeti et al, 2004;Duda et al, 2005;Sabeti et al, 2005;Duda et al, 2006) with a restenosis rate as low as 17.9% at eighteen months (Duda et al, 2005) and patency rates of more than 85% at 18 months (Henry et al, 1996). In contrast, angioplasty had restenosis rates of 40%-60% after one year (Dormandy and Rutherford, 2000) and stainless steel balloon-expandable stents had patency rates of 54% after one year (Gordon et al, 2001).…”