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Observational Study
. 2025 Apr;48(4):427-437.
doi: 10.1007/s00270-025-04003-z. Epub 2025 Mar 19.

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

Ralf Langhoff #  1 , Zsolt Vajda #  2   3 , Piotr Odrowąż-Pieniążek  4   5 , Aleksandar Gjoreski  6 , Roel Beelen  7 , Koen Deloose  8 , Balázs Nemes  9 , Zoltán Ruzsa  10   11 , Jean-Luc Banos  12 , Sérgio Castro  13 , Benjamin Faurie  14 , Torsten Fuß  15 , Michael Piorkowski  16 , Istvan Király  17 , Ivan Vulev  18 , Arne Schwindt  19 , Péter Csécsei  20 , Alejandro Tomasello Weitz  21 , Tomáš Jonszta  22   23 , Paweł Latacz  24 , Jorge Galván Fernández  25 , Jürgen Verbist  26 , Henrik Schröder  27 , Christiane Pöckler-Schöniger  28 , Karlis Kupcs  29   30 , Pascual Lozano Vilardell  31 , Rubén Rodríguez Carvajal  32 , Kim Daenens  33 , Matthias Tenholt  34 , Peter Blaško  35 , Olivier François  36 , José Luis Diaz Valiño  37 , Francisco Javier Martínez Gámez  38 , Volker Sesselmann  39 , Pál Bárzo  40 , Wiebke Kurre  41 , Mikel Terceño Izaga  42 , Antonio Orgaz Pérez-Grueso  43 , Karol Suppan  44 , Jiří Lacman  45 , José Angel Larrea Peña  46 , Jordi Blasco  47 , Reinoud Bokkers  48 , Vladimir Cvetić  49 , Viktor Till  50 , Heliodoro Vallés González  51 , Martin Andrassy  52 , Daniel van den Heuvel  53 , Jürgen Köhler  54 , Stefan Müller-Hülsbeck #  55 , Sasko Kedev #  56
Affiliations
Observational Study

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

Ralf Langhoff et al. Cardiovasc Intervent Radiol. 2025 Apr.

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.

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Conflict of interest statement

Declarations. Conflict of interest: AS: Consultancy for Terumo; BF: Consultancy for Terumo (CAS Workshops); BN: Consultancy for Boston Scientific, Biotronik, Cook, Bentley, Penumbra; JB: Speaker for Stryker Neurovascular; Medtronic, CEC member of the Inspire-S and Inspire-A registries; J-LB: Consultancy for Terumo (CAS Workshops); KDe: Consultancy for Abbott, BD, Bentley, Biotronik, Boston Scientific, Cook, Cordis, Getinge, Gore, iVascular, Penumbra, Philips, Terumo; MP: Honoraria, institutional grants for research, clinical trials from: Abbott Vascular, Boston Scientific Corp., Gore & Associates, Inari Medical, Philips-Spectranetics, PQ-Bypass, Reflow Medical, Reva Medical, Terumo, TriReme, Veryan; OF: Consultancy for iVascular, Cerenovus, GE Healthcare; PO-P: Fees for conducting proctoring CAS procedures from Boston, Medtronic, Terumo; RB: Consultancy for Terumo; RL: Advisory board member, lecture honoraria, scientific grants from Abbott Vascular, Alvimedica, Boston Scientific, BD Bard, B.Braun, Biotronik, Contego Medical, Cardionovum, iVascular, Medtronic, Terumo; RRC: Consultancy for Boston Scientifics, Abbott Vascular; SK: Consultancy for Terumo; SM-H: Consultancy for Eurocor, Alvimedica, Terumo; TF: Consultancy for Terumo, Biotronik, BD, BSCI, Abbott. Ethical Approval: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The Institutional Review Board of each participating centre approved the study as per local regulations. Informed Consent: Informed consent was obtained from all individual participants included in the study. Consent for Publication: Consent for publication was obtained for every individual person’s data included in the study.

Figures

Fig. 1
Fig. 1
The patient disposition flow-chart. *Patients were enrolled if compliant with the eligibility criteria and after successful guidewire passage through the target lesion. **Analyses included 1965 enrolled patients who received the study device
Fig. 2
Fig. 2
The forest plot summarizes the results of the multivariable logistic regression modelling, which identified several unique predictors of 30-day MAE. Odds ratios (with 95% CIs) and p-values of variables significant at 5% level are shown in bold. CI: Confidence Interval; IDDM: Insulin-Dependent Diabetes Mellitus; NIDDM: Non-Insulin-Dependent Diabetes Mellitus; OR: Odds Ratio
See this image and copyright information in PMC

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