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, physicianinitiated 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.

Bosiers, M., Deloose, K., Torsello, G., Scheinert, D., Maene, L., Peeters, P., et al. (2016). The clear-road study: Evaluation of a new dual layer micromesh stent system for the carotid artery. EUROINTERVENTION, 12(5), e671-e676 [10.4244/EIJY16M05_04].

The clear-road study: Evaluation of a new dual layer micromesh stent system for the carotid artery

SETACCI, CARLO
2016-01-01

Abstract

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, physicianinitiated 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.
2016
Bosiers, M., Deloose, K., Torsello, G., Scheinert, D., Maene, L., Peeters, P., et al. (2016). The clear-road study: Evaluation of a new dual layer micromesh stent system for the carotid artery. EUROINTERVENTION, 12(5), e671-e676 [10.4244/EIJY16M05_04].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11365/996493
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