CardioVascular and Interventional Radiology

, Volume 39, Issue 11, pp 1541–1549 | Cite as

Incidence of New Ischaemic Brain Lesions After Carotid Artery Stenting with the Micromesh Roadsaver Carotid Artery Stent: A Prospective Single-Centre Study

  • Maria Antonella RuffinoEmail author
  • Riccardo Faletti
  • Laura Bergamasco
  • Paolo Fonio
  • Dorico Righi
Clinical Investigation



Several randomized trials of patients with carotid stenosis show increased adverse neurological events with stenting versus endarterectomy in the 30-day post-procedure. This study examines the incidence of new ischaemic lesions in patients treated in our centre using the new Roadsaver stent.

Methods and results

Between September 2015 and January 2016, 23 consecutive patients (age 74.3 ± 7.3 years, 17.4 % female) underwent carotid artery stenting with the Roadsaver stent, a nitinol double-layer micromesh device. A distal protection device was used in all cases. Diffusion-weighted magnetic resonance imaging was performed 24 h before, and 24 h and 30 days after the procedure. The 24-h post-procedure imaging showed 15 new ipsilateral ischaemic lesions in 7 (30.4 %) patients: median volume 0.076 cm3 (interquartile range 0.065–0.146 cm3). All lesions were asymptomatic. The 30-day imaging showed complete resolution of all lesions and no new ischaemic lesions. Follow-up clinical and ultrasound examinations at 30 days and 6 months recorded no adverse cardiac or cerebrovascular events.


Protected stenting with micromesh Roadsaver stent showed good safety and efficacy in the treatment of carotid stenosis, with a low incidence of delayed embolic events and new ipsilateral ischaemic brain lesions. These preliminary results are encouraging, but need to be confirmed with larger populations.


Internal carotid artery stenosis Carotid stenting Micromesh stent Embolic protection Diffusion-weighted magnetic resonance Ischaemic brain lesions 


Author Contribution

MAR and RF designed the protocol of the study, MAR submitted it to ethical committee for approval. LB analysed the data and performed the statistical analysis, and PF and DR gave the final approval of the manuscript submitted. All the authors give their written consent to be named in the manuscript.

Compliance with Ethical Standards

Conflict of Interest

There is no financial arrangement or other relationship that could be construed as a conflict of interest for each and every one of listed authors.

Ethical Approval

All procedures performed in this study were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This study does not contain any studies with animals performed by any of the authors.

Informed Consent

Informed consent was obtained from all individual participants included in the study. Additional informed consent was obtained from all individual participants for whom identifying information is included in this article: does not apply.


  1. 1.
    Brott TG, Hobson RW 2nd, Howard G, Roubin GS, Clark WM, Brooks W, Mackey A, Hill MD, Leimngruber PP, Sheffet AJ, Howard VJ, Moore WS, Voeks JH, Hopkins LN, Cutlip DE, Cohen DJ, Popma JJ, Ferguson RD, Cohen SN, Blackshear JL, Silver FL, Mohr JL, Lal BK, Meschia JF, CREST investigators. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med. 2010;363:11–23.CrossRefPubMedPubMedCentralGoogle Scholar
  2. 2.
    Bonati LH, Dobson J, Featherstone RL, Ederle J, van der Worp HB, de Borst GJ, Mali WP, Beard JD, Cleveland T, Engelter ST, Lyrer PA, Ford GA, Dorman PJ, Brown MM, Interational carotid stenting study investigators. Long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: the international carotid stenting study (ICSS) randomised trial. Lancet. 2015;385:529–38.CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Ederle J, Dobson J, Featherstone RL, Bonati LH, van der Worp HB, de Borst GJ, Lo TH, Gaines P, Dorman PJ, Macdonald S, Lyrer PA, hendriks JM, McCollum C, Nederkoorn PJ, Brown MM, International carotid stenting study investigators. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (international carotid stenting study): an interim analysis of a randomised controlled trial. Lancet. 2010;375:985–97.CrossRefPubMedGoogle Scholar
  4. 4.
    Bonati LH, Jongen LM, Haller S, Flach HZ, Dobson J, Nederkoom PJ, Macdonald S, Gaines PA, Waaijer A, Stierli P, Jager HR, Lyrer PA, Kappelle LJ, Wetzwl SG, van der Lugt A, Mali WP, Brown MM, van der Worp HB, Engelter ST, ICSS-MRI study group. New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the international carotid stenting study (ICSS). Lancet Neurol. 2010;9:353–62.CrossRefPubMedGoogle Scholar
  5. 5.
    Cano MN, Kambara AM, de Cano SJ, Pezzi Portela LA, Paes AT, Costa JR, Abizaid AA, Moreira SM, Sousa G, Sousa JE. Randomized comparison of distal and proximal cerebral protection during carotid artery stenting. JACC Cardiovasc Interv. 2013;6:1203–9.CrossRefPubMedGoogle Scholar
  6. 6.
    Palombo G, Stella N, Faraglia V, Taurino M. Aortic arch catheterization during transfemoral carotid artery stenting: an underestimated source of cerebral emboli. Acta Chir Belg. 2010;110:165–8.CrossRefPubMedGoogle Scholar
  7. 7.
    Kim HJ, Lee HJ, Yang JH, Yeo IS, Yi JS, Lee IW, Lee SB, Ryu SY, Kim JK, Yang PS. The influence of carotid artery catheterization technique on the incidence of thromboembolism during carotid artery stenting. AJNR Am J Neuroradiol. 2010;31:1732–6.CrossRefPubMedGoogle Scholar
  8. 8.
    Doig D, Turner EL, Dobson J, Featherson RL, Lo RT, Gaines PA, Macdonald S, Bonati LH, Clifton A, Brown MM, ICSS Investigators. Predictors of stroke, myocardial infarction, or death within 30 days of carotid artery stenting: results from the international carotid stenting study. Eur J Vasc Endovasc Surg. 2016;51(3):327–34.CrossRefPubMedPubMedCentralGoogle Scholar
  9. 9.
    Schofer J, Musialek P, Bijuklic K, Kolvenbach R, Trystula M, Siudeak Z, Sievert H. A prospective, multicenter study of a novel mesh-covered carotid stent: the CGuard CARENET trial (carotid embolic protection using micronet). J Am Coll Cardiol. 2015;8:1229–34.CrossRefGoogle Scholar
  10. 10.
    Hopf-Jensen S, Marques L, Preiss M, Muller-Hulsbeck S. Initial clinical experience with the micromesh roadsaver carotid artery stent for the treatment of patients with symptomatic carotid artery disease. J Endovasc Surg. 2015;22:220–5.Google Scholar
  11. 11.
    North American Symptomatic Carotid Endarterectomy Trial Collaborators. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991;325:445–53.CrossRefGoogle Scholar
  12. 12.
    Setacci C, Chisci E, Setacci F, iavoponi F, de Donato G. Grading carotid intrastent restenosis: a 6-year follow-up study. Stroke. 2008;39:1189–96.CrossRefPubMedGoogle Scholar
  13. 13.
    Bijuklic K, Wandler A, Hazizi F, Schofer J. The PROFI study (prevention of cerebral embolization by proximal balloon occlusion compared to filter protection during carotid artery stenting): a prospective randomized trial. J Am Coll Cardiol. 2012;59:1383–9.CrossRefPubMedGoogle Scholar
  14. 14.
    Gensicke H, van der Worp HB, Nederkoorn PJ, Macdonald S, Gaines PA, van der Lugt A, Mali WP, Lyrer PA, Peters N, Featherstone RL, de Borst GJ, Engelter ST, Brown MM, Bonati LH, ICSS-MRI Substudy Investigators. Ischaemic brain lesions after carotid artery stenting increase future cerebrovascular risk. J Am Coll Cardiol. 2015;65:521–9.CrossRefPubMedPubMedCentralGoogle Scholar
  15. 15.
    Huang KL, HO MY, Chang CH, Ryu SJ, Wong HF, Hsieh IC, Chang TY, Wu TC, Lee TH, Chang YJ. Impact of silent ischaemic lesions on cognition following carotid artery stenting. Eur Radiol. 2011;66:351–8.Google Scholar

Copyright information

© Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2016

Authors and Affiliations

  1. 1.Vascular Radiology Unit, Department of Diagnostic Imaging and RadiotherapyAzienda Ospedaliera Universitaria- Città della Salute e della Scienza di Torino, San Giovanni Battista HospitalTurinItaly
  2. 2.Radiology Unit, Department of Surgical SciencesUniversity of Torino, Azienda Ospedaliera Universitaria- Città della Salute e della Scienza di Torino, San Giovanni Battista HospitalTurinItaly
  3. 3.Department of Surgical SciencesUniversity of Torino, Azienda Ospedaliera Universitaria- Città della Salute e della Scienza di Torino, San Giovanni Battista HospitalTurinItaly

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