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The CLEAR-ROAD study: evaluation of a new dual layer micromesh stent system for the carotid artery.

PMID: 27180304 (view PubMed database entry)
DOI: 10.4244/eijy16m05_04 (read at publisher's website )

Marc Bosiers, Koen Deloose, Giovanni Torsello, Dierk Scheinert, Lieven Maene, Patrick Peeters, Stefan Müller-Hülsbeck, Horst Sievert, Ralf Langhoff, Michel Bosiers, Carlo Setacci,

<h4>Aims</h4>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.<h4>Methods and results</h4>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.<h4>Conclusions</h4>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.

EuroIntervention (EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology)
[2016, 12(5):e671-6]

Cited: 17 times

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