Prospective randomized, single-blind, multicenter control clinical study of sirolimus-eluting coronary stent “Calypso” vs everolimus-eluting coronary stent “Xience Prime”: design and rationale for “PATRIOT” trial

Автор: Prokhorikhin Aleksei A., Verin V.V., Osiev A.G., Ganyukov V.I., Protopopov A.V., Dyomin V.V., Abugov S.A., Baystrukov V.I., Grazhdankin I.O., Ponomaryov D.N., Kretov E.I.

Журнал: Патология кровообращения и кардиохирургия @journal-meshalkin

Рубрика: Протокол исследования

Статья в выпуске: 4 т.20, 2016 года.

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Aim. This study is aimed at evaluating the efficacy and safety of sirolimus-eluting coronary stent “Calypso” in comparison with everolimus-eluting coronary stent “Xience Prime” in patients with ischemic heart disease. Methods. This is a prospective, randomized, single-blind multicenter clinical trial in patients undergoing coronary revascularization with coronary stenting. Seven clinical sites in Russia will enroll 610 patients with coronary artery disease. Patients suitable for coronary stenting will be randomized in group 1 (n=406) to receive coronary stent “Calypso” (“Angioline”, and group 2 (n=204) to receive coronary stent Xience Prime (Abbott). Clinical follow-up will continue for 1 year. By the end of follow-up, a quantitative coronary angiography will be performed in 122 patients (20 %). Conclusion. A randomized trial “PATRIOT” is designed to prove the efficacy and safety of sirolimus-eluting coronary stent “Calypso” in comparison with everolimus-eluting coronary stent “Xience Prime” in patients with ischemic heart disease.

Еще

Ischemic heart disease, coronary artery disease, stent, revascularization, calypso, xience prime, patriot

Короткий адрес: https://sciup.org/142140774

IDR: 142140774   |   DOI: 10.21688-1681-3472-2016-4-96-101

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