INITIAL EXPERIENCE WITH RUSSIAN NITINOL STENTS FOR ARTERIAL REVASCULARIZATION

L.S. Kokov, A.N. Balan, A.V. Pokrovsky, A.V. Protopopov, A.P. Perevalov, V.A. Ivanov, N.R. Chernaya, K.V. Hohriakov, A.F. Harazov
Department of Radiological Endovacular Surgery, Vascular Surgery Department,
A.V. Vishnevsky Institute of Surgery, RAMS,
Moscow, Russia

Experimental and clinical trials were carried out from June 1997 to test new nitinol stents with modified design, developed and manufactured by "COMED", Russia. Experimental implantation of 10 stents into 9 mongrel dogs demonstrated bioinertness, low thrombogenicity of the device and long-term preservation of stented vascular lumen. In 7 hospitals in Moscow, Izhevsk and Krasnoyarsk 49 stents were implanted to 39 patients, aged from 38 to 75 (mean 48.6±8.2) including 5 patients with double implantation into the same arterial segment (2 stents with total length of 15 mm). In 3 patients 2 different arterial segments were stented simultaneously. Stented arteries included: coronary – in 3 patients, brachiocephalic trunk in 1 patient, subclavian – in 1 patient, renal – in 11 patients, iliac – in 19 patients, femoral – in 3 patients, popliteal – in 1 patient. Results of multicenter clinical trial demonstrated high technological and clinical quality of a new Russian nitinol stent. Its design successfully combines the most important properties of matrix and self-expanding stents. Minimal shortening during implantation enables precise positioning of the stent inside the vessel and use of dilative balloon for its implantation. High flexibility facilitates delivering it to extensively coiled arteries. Special design of the device – cells geometry and interconnection, enriches it with additional features – ability to eradicate coiling, restore not only vascular lumen, but regular cylindrical form of stented segment as well.

KEY WORDS: nitinol stent, arterial stenoses.

P. 20-29

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