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

Прохорихин, А. А.; Верин, В. В.; Осиев, А. Г.; Ганюков, В. И.; Протопопов, А. В.; Демин, В. В.; Абугов, С А; Байструков, В. И.; Grazhdankin, Igor; Ponomarev, Dmitry; Кретов, Е. И.

doi:10.21688/1681-3472-2016-4-96-101

Cited by 3 publications

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“…Это клиническое исследова-ние выполняют на территории России с участием 7 медицинских центров и включением 610 пациентов [36] старше 18 лет, подписавших информированное согласие, которым показана имплантация стента с лекарственным покрытием для лечения стабильной ишемической болезни сердца или острого коронар-ного синдрома. Пациентов включали в исследование при поражении коронарной артерии с референсным диаметром артерии от 2,5 до 4,5 мм и стенозом бо-лее 50%.…”

Section: предстоящие клинические исследованияunclassified

A modern generation of drug-eluting stents. Focusing on a sirolimus-eluting stent Calypso

Кудряшов¹,

Требушат²,

Верин³

et al. 2017

PKiK

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The review deals with the evolution of interventional coronary procedures and development of the state-of-art coronary stent market. Emphasis in the review is placed on comprehensive analysis of technical characteristics of the world’s most popular coronary stents versus a Russian bioresorbable sirolimus-eluting stent “Calipso”.Received 13 January 2017. Accepted 17 March 2017.Conflict of interest: Kudryashov A.N., Trebushat D.V. are “Angioline” Company employees, the producer of “Kalipso” coronary stent. Kretov E.I. served as executive editor of “Endovascular surgery” section. All other authors declare no conflict of interest.

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Section: предстоящие клинические исследованияunclassified

A modern generation of drug-eluting stents. Focusing on a sirolimus-eluting stent Calypso

Кудряшов¹,

Требушат²,

Верин³

et al. 2017

PKiK

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“…Как первый произведенный в России и разрешенный к продаже сиролимус-выделяющий лекарственный стент с биодеградируемым покрыти-ем, он интересен российскому сообществу рентге-нэндоваскулярной диагностики и лечения, в связи с чем наиболее полное исследование возможностей применения данного устройства является задачей но-мер один для интервенционной кардиологии в стра-не [6].…”

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Prospective study one-year clinical outcomes of the Calypso coronary stent in patients presenting with acute coronary syndrome

Воробьев¹,

Семенихин²,

Грачев³

et al. 2017

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Aim. To evaluate the effectiveness of the stent use Calypso Angiolain Russia with primary percutaneous transluminal coronary angioplasty (PTCA). Methods. The study prospectively included 150 patients who underwent PTCA in acute coronary syndrome (ACS) for the period from January to December 2015. During the one-year follow-up period were evaluated indicators insolvency target lesion (cardiac death, myocardial infarction in the pool target artery, target lesion revascularization when clinically indicated), major adverse cardiac events (death from any cause, myocardial infarction, repeat revascularization as clinically indicated). Results. In one year, the incidence of target lesion failure was 6.66% for cardiac death rate of 1.33%, myocardial infarction in the target artery 3.33% and target lesion revascularization at 5.3%. The frequency of cardiac major adverse cardiac events was 12% at mortality 2.66%, myocardial infarction 4% and revascularization when clinically indicated 8.66%. Conclusion. The use of stents in primary PTCA Calypso is possible, the percentage of cardiovascular complications is comparable with the data of clinical trials.Received 31 January 2017. Accepted 17 March 2017.Financing: The study did not have sponsorship.Conflict of interest: The authors declare no conflict of interest.

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Clinical rationale and experimental feasibility of the first national drug-eluting stent platform

Kretov,

Baystrukov,

Boykov

et al. 2020

Kompleks. probl. serdečno-sosud. zabol.

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Background.The availability of drug-eluting stents with evidence-based clinical safety and efficacy produced in the Russian Federation is one of the relevant goals for successful treating of patients with coronary artery disease, including acute coronary syndrome. Aim To confirm clinical rationale and experimental feasibility of the first Russian drugeluting stent, Calypso (Angioline, LLC, Russian Federation), for the clinical practice.Methods.The study included four phases. The first phase was aimed at selecting the optimal stent platform with superior healing properties. Then, the selected Russian coronary stents based on the optimal platforms underwent preclinical studies. The third phase included the clinical assessment using optical coherence tomography (OCT) in order to confirm the preclinical results. The last phase was focused on assessing clinical safety and efficacy of the Russian coronary stent based on the comparative analysis of angiographic findings within the 12-months follow-up.Results.At the first phase, biodegradable polymer sirolimus-eluting stent showed superior healing properties in comparison with the healing score of 18±14.97 for Orsiro stents (Biotronik, Germany) versus 25.6±1.0 for Xience stents (Abbott Vascular, USA) versus 32.5±20.3 for Synergy (Boston Scientific, USA), p<0.001. The Russian stent consistently demonstrated a high healing profile in preclinical and OCT clinical studies. The results of the comparative clinical study proved the clinical safety and efficacy of the Russian stent that was similar to the best foreign stents. None of the differences in the incidence of binary restenosis were found between the groups (p<0.05).Conclusion.The biodegradable polymer sirolimus-eluting stent Calypso manufactured in the Russian Federation demonstrated superior neointimal healing pattern with no signs of chronic inflammation in the experiment. This stent reported high neointimal healing properties according to the clinical OCT study. According to the angiographic findings, the incidence of binary restenosis between the Russian biodegradable polymer sirolimus-eluting stent and durable polymer everolimuseluting stents was similar at the 12-months follow-up (p>0.05).

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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

Cited by 3 publications

References 1 publication

A modern generation of drug-eluting stents. Focusing on a sirolimus-eluting stent Calypso

A modern generation of drug-eluting stents. Focusing on a sirolimus-eluting stent Calypso

Prospective study one-year clinical outcomes of the Calypso coronary stent in patients presenting with acute coronary syndrome

Clinical rationale and experimental feasibility of the first national drug-eluting stent platform

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