AIMS: The aim of this study was to evaluate the 30-day clinical outcome of treatment using the Roadsaver carotid stent in non-consecutive subjects at high risk for carotid endarterectomy requiring revascularisation. METHODS AND RESULTS: The CLEAR-ROAD study is a prospective, multinational, single-arm, physician-initiated study planned to include 100 patients in nine centres in Belgium, Italy and Germany. The primary endpoint was the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any death, stroke or myocardial infarction (MI). The use of embolic protection devices (EPDs) was not mandatory; 31.0% of the patients were symptomatic and in 58.0% of the patients EPDs were used. Technical success was achieved in all cases. The 30-day MAE rate was 2.1% (one patient experienced MI followed by death; another patient experienced a stroke within the first 30 days after procedure). While no statistical analysis could be performed, subgroup data suggested that there were no notable differences in the 30-day MAE rate between symptomatic and asymptomatic patients, or between EPD use. CONCLUSIONS: The 30-day clinical outcome of 100 patients treated with a dual layer micromesh carotid stent (Roadsaver) shows promising results. The Roadsaver stent is a safe and effective device for endovascular treatment of subjects at high risk for carotid endarterectomy.
AIMS: The aim of this study was to evaluate the 30-day clinical outcome of treatment using the Roadsaver carotid stent in non-consecutive subjects at high risk for carotid endarterectomy requiring revascularisation. METHODS AND RESULTS: The CLEAR-ROAD study is a prospective, multinational, single-arm, physician-initiated study planned to include 100 patients in nine centres in Belgium, Italy and Germany. The primary endpoint was the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any death, stroke or myocardial infarction (MI). The use of embolic protection devices (EPDs) was not mandatory; 31.0% of the patients were symptomatic and in 58.0% of the patients EPDs were used. Technical success was achieved in all cases. The 30-day MAE rate was 2.1% (one patient experienced MI followed by death; another patient experienced a stroke within the first 30 days after procedure). While no statistical analysis could be performed, subgroup data suggested that there were no notable differences in the 30-day MAE rate between symptomatic and asymptomatic patients, or between EPD use. CONCLUSIONS: The 30-day clinical outcome of 100 patients treated with a dual layer micromesh carotid stent (Roadsaver) shows promising results. The Roadsaver stent is a safe and effective device for endovascular treatment of subjects at high risk for carotid endarterectomy.
Authors: Ján Sýkora; Kamil Zeleňák; Martin Vorčák; Martin Števík; Martina Sýkorová; Jozef Sivák; Marek Rovňák; Jana Zapletalová; Juraj Mužík; Igor Šinák; Egon Kurča; Lukas Meyer; Jens Fiehler Journal: Cardiovasc Intervent Radiol Date: 2022-07-07 Impact factor: 2.797
Authors: Roman Machnik; Piotr Paluszek; Łukasz Tekieli; Karolina Dzierwa; Damian Maciejewski; Mariusz Trystuła; Andrzej Brzychczy; Krzysztof Banaszkiewicz; Robert Musiał; Piotr Pieniążek Journal: Postepy Kardiol Interwencyjnej Date: 2017-05-30 Impact factor: 1.426
Authors: Roman A Machnik; Piotr Pieniążek; Marcin Misztal; Krzysztof Plens; Marek Kazibudzki; Tomasz Tomaszewski; Andrzej Brzychczy; Robert Musiał; Mariusz Trystuła; Łukasz M Tekieli Journal: Postepy Kardiol Interwencyjnej Date: 2020-12-29 Impact factor: 1.426
Authors: Adam Mazurek; Krzysztof Malinowski; Kenneth Rosenfield; Laura Capoccia; Francesco Speziale; Gianmarco de Donato; Carlo Setacci; Christian Wissgott; Pasqualino Sirignano; Lukasz Tekieli; Andrey Karpenko; Waclaw Kuczmik; Eugenio Stabile; David Christopher Metzger; Max Amor; Adnan H Siddiqui; Antonio Micari; Piotr Pieniążek; Alberto Cremonesi; Joachim Schofer; Andrej Schmidt; Piotr Musialek Journal: J Clin Med Date: 2022-08-17 Impact factor: 4.964