30-Day Outcomes of Real-World Elective Carotid Stenosis Treatment Using a Dual-Layer Micromesh Stent (ROADSAVER Study)

Ralf Langhoff; Zsolt Vajda; Piotr Odrowąż-Pieniążek; Aleksandar Gjoreski; Roel Beelen; Koen Deloose; Balázs Nemes; Zoltán Ruzsa; Jean Luc Banos; Sérgio Castro; Benjamin Faurie; Torsten Fuß; Michael Piorkowski; Istvan Király; Ivan Vulev; Arne Schwindt; Péter Csécsei; Alejandro Tomasello Weitz; Tomáš Jonszta; Paweł Latacz; Jorge Galván Fernández; Jürgen Verbist; Henrik Schröder; Christiane Pöckler-Schöniger; Karlis Kupcs; Pascual Lozano Vilardell; Rubén Rodríguez Carvajal; Kim Daenens; Matthias Tenholt; Peter Blaško; Olivier François; José Luis Diaz Valiño; Francisco Javier Martínez Gámez; Volker Sesselmann; Pál Bárzo; Wiebke Kurre; Mikel Terceño Izaga; Antonio Orgaz Pérez-Grueso; Karol Suppan; Jiří Lacman; José Angel Larrea Peña; Jordi Blasco; Reinoud Bokkers; Vladimir Cvetić; Viktor Till; Heliodoro Vallés González; Martin Andrassy; Daniel van den Heuvel; Jürgen Köhler; Stefan Müller-Hülsbeck; Sasko Kedev

doi:10.1007/s00270-025-04003-z

30-Day Outcomes of Real-World Elective Carotid Stenosis Treatment Using a Dual-Layer Micromesh Stent (ROADSAVER Study)

Ralf Langhoff
, Zsolt Vajda
, Piotr Odrowąż-Pieniążek
, Aleksandar Gjoreski
, Roel Beelen
, Koen Deloose
, Balázs Nemes
, Zoltán Ruzsa
, Jean Luc Banos
, Sérgio Castro
, Benjamin Faurie
, Torsten Fuß
, Michael Piorkowski
, Istvan Király
, Ivan Vulev
, Arne Schwindt
, Péter Csécsei
, Alejandro Tomasello Weitz
, Tomáš Jonszta
, Paweł Latacz

Jorge Galván Fernández, Jürgen Verbist, Henrik Schröder, Christiane Pöckler-Schöniger, Karlis Kupcs, Pascual Lozano Vilardell, Rubén Rodríguez Carvajal, Kim Daenens, Matthias Tenholt, Peter Blaško, Olivier François, José Luis Diaz Valiño, Francisco Javier Martínez Gámez, Volker Sesselmann, Pál Bárzo, Wiebke Kurre, Mikel Terceño Izaga, Antonio Orgaz Pérez-Grueso, Karol Suppan, Jiří Lacman, José Angel Larrea Peña, Jordi Blasco, Reinoud Bokkers, Vladimir Cvetić, Viktor Till, Heliodoro Vallés González, Martin Andrassy, Daniel van den Heuvel, Jürgen Köhler, Stefan Müller-Hülsbeck^*, Sasko Kedev

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

3 Citations (Scopus)

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Abstract

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).

Original language	English
Pages (from-to)	427-437
Number of pages	11
Journal	Cardiovascular and interventional radiology
Volume	48
Issue number	4
DOIs	https://doi.org/10.1007/s00270-025-04003-z
Publication status	Published - Apr-2025

Keywords

Carotid artery disease
Carotid artery revascularization
Carotid artery stenting
Cerebrovascular embolic protection
Stroke prevention

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30-Day Outcomes of Real-World Elective Carotid Stenosis Treatment Using a Dual-Layer Micromesh Stent (ROADSAVER Study)Final publisher's version, 622 KBLicence: CC BY

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Langhoff, R., Vajda, Z., Odrowąż-Pieniążek, P., Gjoreski, A., Beelen, R., Deloose, K., Nemes, B., Ruzsa, Z., Banos, J. L., Castro, S., Faurie, B., Fuß, T., Piorkowski, M., Király, I., Vulev, I., Schwindt, A., Csécsei, P., Tomasello Weitz, A., Jonszta, T., ... Kedev, S. (2025). 30-Day Outcomes of Real-World Elective Carotid Stenosis Treatment Using a Dual-Layer Micromesh Stent (ROADSAVER Study). Cardiovascular and interventional radiology, 48(4), 427-437. https://doi.org/10.1007/s00270-025-04003-z

@article{dfc6961159d84e45a133f9f0d1792ddc,

title = "30-Day Outcomes of Real-World Elective Carotid Stenosis Treatment Using a Dual-Layer Micromesh Stent (ROADSAVER Study)",

abstract = "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).",

keywords = "Carotid artery disease, Carotid artery revascularization, Carotid artery stenting, Cerebrovascular embolic protection, Stroke prevention",

author = "Ralf Langhoff and Zsolt Vajda and Piotr Odrow{\c a}{\.z}-Pieni{\c a}{\.z}ek and Aleksandar Gjoreski and Roel Beelen and Koen Deloose and Bal{\'a}zs Nemes and Zolt{\'a}n Ruzsa and Banos, \{Jean Luc\} and S{\'e}rgio Castro and Benjamin Faurie and Torsten Fu{\ss} and Michael Piorkowski and Istvan Kir{\'a}ly and Ivan Vulev and Arne Schwindt and P{\'e}ter Cs{\'e}csei and \{Tomasello Weitz\}, Alejandro and Tom{\'a}{\v s} Jonszta and Pawe{\l} Latacz and \{Galv{\'a}n Fern{\'a}ndez\}, Jorge and J{\"u}rgen Verbist and Henrik Schr{\"o}der and Christiane P{\"o}ckler-Sch{\"o}niger and Karlis Kupcs and \{Lozano Vilardell\}, Pascual and \{Rodr{\'i}guez Carvajal\}, Rub{\'e}n and Kim Daenens and Matthias Tenholt and Peter Bla{\v s}ko and Olivier Fran{\c c}ois and \{Diaz Vali{\~n}o\}, \{Jos{\'e} Luis\} and \{Mart{\'i}nez G{\'a}mez\}, \{Francisco Javier\} and Volker Sesselmann and P{\'a}l B{\'a}rzo and Wiebke Kurre and \{Terce{\~n}o Izaga\}, Mikel and \{Orgaz P{\'e}rez-Grueso\}, Antonio and Karol Suppan and Ji{\v r}{\'i} Lacman and \{Larrea Pe{\~n}a\}, \{Jos{\'e} Angel\} and Jordi Blasco and Reinoud Bokkers and Vladimir Cveti{\'c} and Viktor Till and \{Vall{\'e}s Gonz{\'a}lez\}, Heliodoro and Martin Andrassy and \{van den Heuvel\}, Daniel and J{\"u}rgen K{\"o}hler and Stefan M{\"u}ller-H{\"u}lsbeck and Sasko Kedev",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2025.",

year = "2025",

month = apr,

doi = "10.1007/s00270-025-04003-z",

language = "English",

volume = "48",

pages = "427--437",

journal = "Cardiovascular and interventional radiology",

issn = "0174-1551",

publisher = "Springer",

number = "4",

}

Langhoff, R, Vajda, Z, Odrowąż-Pieniążek, P, Gjoreski, A, Beelen, R, Deloose, K, Nemes, B, Ruzsa, Z, Banos, JL, Castro, S, Faurie, B, Fuß, T, Piorkowski, M, Király, I, Vulev, I, Schwindt, A, Csécsei, P, Tomasello Weitz, A, Jonszta, T, Latacz, P, Galván Fernández, J, Verbist, J, Schröder, H, Pöckler-Schöniger, C, Kupcs, K, Lozano Vilardell, P, Rodríguez Carvajal, R, Daenens, K, Tenholt, M, Blaško, P, François, O, Diaz Valiño, JL, Martínez Gámez, FJ, Sesselmann, V, Bárzo, P, Kurre, W, Terceño Izaga, M, Orgaz Pérez-Grueso, A, Suppan, K, Lacman, J, Larrea Peña, JA, Blasco, J, Bokkers, R, Cvetić, V, Till, V, Vallés González, H, Andrassy, M, van den Heuvel, D, Köhler, J, Müller-Hülsbeck, S & Kedev, S 2025, '30-Day Outcomes of Real-World Elective Carotid Stenosis Treatment Using a Dual-Layer Micromesh Stent (ROADSAVER Study)', Cardiovascular and interventional radiology, vol. 48, no. 4, pp. 427-437. https://doi.org/10.1007/s00270-025-04003-z

TY - JOUR

T1 - 30-Day Outcomes of Real-World Elective Carotid Stenosis Treatment Using a Dual-Layer Micromesh Stent (ROADSAVER Study)

AU - Langhoff, Ralf

AU - Vajda, Zsolt

AU - Odrowąż-Pieniążek, Piotr

AU - Gjoreski, Aleksandar

AU - Beelen, Roel

AU - Deloose, Koen

AU - Nemes, Balázs

AU - Ruzsa, Zoltán

AU - Banos, Jean Luc

AU - Castro, Sérgio

AU - Faurie, Benjamin

AU - Fuß, Torsten

AU - Piorkowski, Michael

AU - Király, Istvan

AU - Vulev, Ivan

AU - Schwindt, Arne

AU - Csécsei, Péter

AU - Tomasello Weitz, Alejandro

AU - Jonszta, Tomáš

AU - Latacz, Paweł

AU - Galván Fernández, Jorge

AU - Verbist, Jürgen

AU - Schröder, Henrik

AU - Pöckler-Schöniger, Christiane

AU - Kupcs, Karlis

AU - Lozano Vilardell, Pascual

AU - Rodríguez Carvajal, Rubén

AU - Daenens, Kim

AU - Tenholt, Matthias

AU - Blaško, Peter

AU - François, Olivier

AU - Diaz Valiño, José Luis

AU - Martínez Gámez, Francisco Javier

AU - Sesselmann, Volker

AU - Bárzo, Pál

AU - Kurre, Wiebke

AU - Terceño Izaga, Mikel

AU - Orgaz Pérez-Grueso, Antonio

AU - Suppan, Karol

AU - Lacman, Jiří

AU - Larrea Peña, José Angel

AU - Blasco, Jordi

AU - Bokkers, Reinoud

AU - Cvetić, Vladimir

AU - Till, Viktor

AU - Vallés González, Heliodoro

AU - Andrassy, Martin

AU - van den Heuvel, Daniel

AU - Köhler, Jürgen

AU - Müller-Hülsbeck, Stefan

AU - Kedev, Sasko

PY - 2025/4

Y1 - 2025/4

N2 - 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).

AB - 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).

KW - Carotid artery disease

KW - Carotid artery revascularization

KW - Carotid artery stenting

KW - Cerebrovascular embolic protection

KW - Stroke prevention

UR - https://www.scopus.com/pages/publications/105000833515

U2 - 10.1007/s00270-025-04003-z

DO - 10.1007/s00270-025-04003-z

M3 - Article

C2 - 40107985

AN - SCOPUS:105000833515

SN - 0174-1551

VL - 48

SP - 427

EP - 437

JO - Cardiovascular and interventional radiology

JF - Cardiovascular and interventional radiology

IS - 4

ER -

30-Day Outcomes of Real-World Elective Carotid Stenosis Treatment Using a Dual-Layer Micromesh Stent (ROADSAVER Study)

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