PURPOSE: Carotid artery stenting with single-layer stents carries a risk of periprocedural cerebral embolization compared to carotid endarterectomy. Dual-layer micromesh stents were designed for improved plaque coverage and sustained embolic protection. This analysis aimed to confirm the Roadsaver dual-layer micromesh stent safety in a real-world carotid artery stenting cohort. MATERIALS AND METHODS: ROADSAVER was a prospective, single-arm, multicenter, observational study. Patients with carotid artery stenosis, eligible for elective stenting, were enrolled at 52 sites across 13 European countries. All procedures followed standard practice. The primary outcome was the 30-day major adverse event rate, defined as the cumulative incidence of any death or stroke. All deaths, strokes, and carotid artery revascularizations were independently adjudicated. RESULTS: In total, 1965 patients were analysed (mean age 70.6 ± 8.8 years). Cerebral ischaemia symptoms were present in 49.4% of participants. Radial/ulnar access was used in 26.3% of cases and embolic protection in 63.8%. The 30-day major adverse event incidence was 2.2% (1.6% in asymptomatic and 2.8% in symptomatic patients), with any stroke at 1.9%, any death at 0.8%, and stroke-related death at 0.5%. Predictors of higher 30-day major adverse event risk, identified through multivariable modelling, included residual stenosis ≥ 30%, thromboembolic venous disease, previous myocardial infarction, age ≥ 75 years, family history of atherosclerosis, non-insulin-dependent diabetes mellitus, symptomatic carotid stenosis, and stent length. CONCLUSION: Dual-layer micromesh carotid artery stenting is safe, with a low 30-day major adverse event incidence in real-world asymptomatic and symptomatic patients, supporting the sustained embolic protection design concept. LEVEL OF EVIDENCE: Level 2, observational study (with dramatic effect).

Angiology and Vascular Surgery Department Hospital Universitari Son Espases Palma Spain

Bács Kiskun County Hospital Teaching Hospital of the Szent Györgyi Albert Medical University Kecskemét Hungary

Cardioangiologisches Centrum Bethanien at Agaplesion Bethanien Hospital Frankfurt Germany

Cardiovascular Radiology Department Clinic for Vascular and Endovascular Surgery University Clinical Centre of Serbia Belgrade Serbia

Center of Radiology Clinical Centre of Vojvodina Novi Sad Serbia

Centre de Cardiologie et d'Exploration de la Côte Basque Bayonne France

Centre of Vasculare Medicine Elblandklinikum Radebeul Radebeul Germany

Clinic for Vascular and Endovascular Surgery Pius Hospital Oldenburg Carl Von Ossietzky Universität Oldenburg Germany

Clinic of Vascular and Internal Diseases Dr Jan Biziel University Hospital No 2 Bydgoszcz Poland

Department for Diagnostic and Interventional Radiology Clinical Hospital Acibadem Sistina Skopje North Macedonia

Department of Angiology Brandenburg Medical School Theodor Fontane Campus Clinic Brandenburg Brandenburg an der Havel and Sankt Gertrauden Hospital Berlin Germany

Department of Cardiology Faculty of Medicine University Clinic of Cardiology University of St Cyril and Methodius Skopje North Macedonia

Department of Diagnostic and Interventional Radiology Neuroradiology Academic Teaching Hospital Christian Albrechts University Kiel Faculty of Medicine Deaconess Hospital Flensburg DIAKO Hospital gGmbH Knuthstraße 1 24939 Flensburg Germany

Department of Interventional Cardiology Institute of Cardiology Medical College Jagiellonian University Kraków Poland

Department of Interventional Cardiology Kardiocentrum Nitra s r o Nitra Slovakia

Department of Interventional Neuroradiology Hospital Clinic of Barcelona Barcelona Spain

Department of Interventional Neuroradiology Hospital Clínico Universitario de Valladolid Valladolid Spain

Department of Interventional Radiology CINRE s r o Bratislava Slovakia

Department of Interventional Radiology Heart and Vascular Centre Semmelweis University Budapest Hungary

Department of Medical Imaging AZ Groeninge Kortrijk Belgium

Department of Radiology and Neuroradiology Klinikum Passau Passau Germany

Department of Radiology Fejér County Szent György University Teaching Hospital Székesfehérvár Hungary

Department of Radiology Medical Imaging Center University Medical Center Groningen University of Groningen Groningen The Netherlands

Department of Radiology Military University Hospital Prague Prague Czech Republic

Department of Radiology Riga Stradiņš University Riga Latvia

Department of Radiology St Antonius Hospital Nieuwegein The Netherlands

Department of Radiology University Hospital Ostrava Ostrava Czech Republic

Department of Vascular and Thoracic Surgery Imelda Hospital Bonheiden Bonheiden Belgium

Department of Vascular and Thoracic Surgery O L 5 Aalst Aalst Belgium

Department of Vascular Surgery and Angiology Brothers of Mercy St John of God Hospital Kraków Poland

Department of Vascular Surgery AZ Sint Blasius Dendermonde Belgium

Department of Vascular Surgery St Franziskus Hospital Münster Germany

Department of Vascular Surgery University Hospitals Leuven Leuven Belgium

Diagnostische Radiologie Neuroradiologie SRH Klinikum Karlsbad Langensteinbach Karlsbad Germany

Division of Invasive Cardiology Department of Internal Medicine University of Szeged Szeged Hungary

Division on Endovascular Therapy Department of Vascular Surgery John Paul 2 Hospital Kraków Poland

Faculty of Medicine Riga Stradiņš University Riga Latvia

Faculty of Medicine University of Ostrava Ostrava Czech Republic

Fuerst Stirum Hospital Cardiology and Vascular Medicine Bruchsal Germany

Ihre Radiologen de Center for Diagnostic Radiology and Minimally Invasive Therapy The Jewish Hospital Berlin Germany

Infirmerie Protestante de Lyon Caluire et Cuire France

International Vascular and Endovascular Institute Angiology and Vascular Surgery Department Hospital Quirónsalud Campo de Gibraltar Palmones Cádiz Spain

Interventional Neuroradiology Section Department of Radiology Donostia University Hospital Donostia San Sebastian Spain

Interventional Neuroradiology Section Department of Radiology Vall d'Hebron University Hospital Barcelona Spain

Interventional Neuroradiology Unit Department of Imagiology Centro Hospitalar Vila Nova de Gaia Espinho Vila Nova de Gaia Portugal

Központi Radiológiai Osztály Markusovszky Egyetemi Oktatókórház Szombathely Szombathely Hungary

Neuroendovascular Division Department of Neurosurgery University of Pécs Pécs Hungary

Neuroradiology Department Hospital Universitario A Coruña A Coruña Spain

Neurosurgery Clinic University of Szeged Hospital Szeged Hungary

Neurovascular Unit Moritz Kaposi Teaching Hospital Kaposvár Hungary

Section of Vascular and Interventional Radiology Department of Radiology Hospital Universitario de Canarias La Laguna Tenerife Spain

Servicio de Angiología y Cirugía Vascular Complejo Hospitalario de Jaén Hospital Universitario Médico Quirúrgico Jaén Spain

Servicio de Angiología y Cirugía Vascular Hospital Universitario de Toledo Toledo Spain

SRH Zentralklinikum Suhl Klinik Für Innere Medizin 1 Suhl Germany

Stroke Unit Department of Neurology Hospital Dr Josep Trueta Institut d'Investigació Biomèdica de Girona Girona Spain

Vein Center Pforzheim Pforzheim Germany

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