“Real-World Study of a Dual-Layer Micromesh Stent in Elective Treatment of Symptomatic and Asymptomatic Carotid Artery Stenosis (ROADSAVER)”

Kedev, Saško; Müller‐Hülsbeck, Stefan; Langhoff, Ralf

doi:10.1007/s00270-021-03051-5

Cited by 8 publications

(5 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Recently, other real-world studies have also confirmed the excellent safety and performance of DLMS during CAS in non-selected patient populations 28,45,48,51,52 . Finally, the ROADSAVER study, the largest real-world DLMS study to date, with close to 2,000 elective patients enrolled, further complements the available clinical evidence on DLMS use in current CAS 53 .…”

Section: Dual-layer Micromesh Stentsmentioning

confidence: 85%

Carotid artery interventions - endarterectomy versus stenting

Kedev

2023

AsiaIntervention

Self Cite

View full text Add to dashboard Cite

Current management of patients with carotid artery stenosis is based on well-established guidelines, including surgical procedures − carotid endarterectomy (CEA) and endovascular carotid artery stenting (CAS) − and optimal medical treatment alone. Outcomes in the postprocedural period after CAS and CEA are similar, suggesting strong clinical durability for both treatments. Recent advances, which include the emergence of novel endovascular treatment tools and techniques, combined with more recent randomised trial data shed new light on optimal patient selection and treatment in contemporary practice. Improved, modern technologies including enhanced embolic protection devices and dual-layered micromesh stents yield better outcomes and should result in further improvements in CAS. In centres of excellence, nowadays, the majority of patients with severe carotid artery stenosis can be successfully treated with either CEA or CAS.

show abstract

Section: Dual-layer Micromesh Stentsmentioning

confidence: 85%

Carotid artery interventions - endarterectomy versus stenting

Kedev

2023

AsiaIntervention

Self Cite

View full text Add to dashboard Cite

show abstract

“…The ROADSAVER is a prospective, multi-center observational study that enrolled approximately 2000 patients across Europe, which evaluated the safety and efficacy of the Roadsaver stent at 30 days and 1 year. The study completion was July 2022, and we await the results for better analysis and evaluation of the Roadsaver carotid stent [25].…”

Section: Discussionmentioning

confidence: 99%

One-Year Outcomes of CGuard Double Mesh Stent in Carotid Artery Disease: A Systematic Review and Meta-Analysis

Tigkiropoulos,

Nikas,

Manolis

et al. 2024

Medicina

View full text Add to dashboard Cite

Background: Prospective single and multicenter studies have shown improved outcomes of patients who underwent carotid artery stenting with the novel CGuard dual-layer mesh stent at 1 year. Objectives: The aim of this study is to conduct a systematic review and meta-analysis of all published studies to assess 1-year efficacy and outcomes of CGuard in patients with carotid stenting. Methods: A systematic search was performed. All studies enrolling at least 20 patients were included in our analysis. The primary endpoints were death (all-cause, cardiovascular and ipsilateral stroke-related death) and stroke rate at 1 year. The secondary endpoint was in-stent restenosis at 1 year. Results: The final analysis included 1709 patients. The one-year all-cause mortality rate was 2.97% (39/1699, 95% CI: 1.26–6.86%, I2 = 67%, t2 = 0.3442, p < 0.01), cardiovascular-related death was 0.92% (10/1616, 95% CI: 0.35–2.39%, I2 = 34%, t2 = 0.2302, p = 0.18), and ipsilateral stroke-related death was 0.3% (1/1649, 95% CI: 0.1–0.87%, I2 = 0%, t2 = 0, p = 0.69). The one-year ipsilateral stroke rate was 1.21% (16/1649, 95% CI: 0.58–2.5%, I2 = 28%, t2 = 0.1433, p = 0.23), transient ischemic attacks (TIAs) rate was 1.78% (19/1149, 95% CI: 1.11–2.84%, I2 = 0%, t2 = 0, p = 0.69), and total composite 1-year stroke/TIA rate was 2.97% (32/1149, 95% CI: 1.84–4.77%, I2 = 0%, t2 = 0, p = 0.41). The in-stent restenosis rate at 1 year was 1.06% (13/1653, 95% CI: 0.48–2.34%, I2 = 28%, t2 = 0.2308, p = 0.22). Conclusions: This meta-analysis shows that CAS with CGuard is safe with minimal neurological adverse events and in-stent restenosis rate at 1 year.

show abstract

“…The DLS thrombosis rate in the present meta-analysis (0.8%) seems to be similar to the results reported by Moulakakis et al 36 They described a series of 674 CAS with standard stents, having four cases (0.6%) of acute thrombosis, possibly secondary to carotid dissections and overlapping of a second stent. 37 …”

Section: Discussionmentioning

confidence: 99%

Carotid Artery Stenting With Double-Layer Stent: A Systematic Review and Meta-Analysis

Pini

Faggioli

Paraskevas³

et al. 2022

J Endovasc Ther

View full text Add to dashboard Cite

Background: Carotid artery stenting (CAS) in the treatment of significant stenosis is a cause of stroke due to both plaque prolapse and cerebral embolization. New types of stents with a double-layer structure have been designed to minimize plaque prolapse and embolization; these double-layer stents (DLSs) should be able to reduce the stroke risk; however, definite data on their performance are scarce in the literature. Methods: A systematic search was performed through PubMed, Scopus, and Cochrane Library, according to PRISMA guidelines; all studies on CAS with DLS (Roadsaver/Casper or CGuard) up to January 1, 2022, with a cohort of at least 20 patients were considered eligible. The present meta-analysis was approved and registered on PROSPERO register (CRD42022297512). Patients with tandem lesions or complete carotid occlusion were excluded from the study. The 30-day stroke rate after CAS was analyzed evaluating the preoperative symptomatic status and DLS occlusion. The estimated pooled rate of events was calculated by random effect model and moderators were evaluated. Results: A total of 14 studies were included in the meta-analysis for a total of 1955 patients. The estimated overall (95% confidence interval [CI]) stroke rate was 1.4% (0.9%–2.2%, I2 = 0%), which was not influenced by the type of DLS used: CGuard 0.8% (0.4%–1.8%, I2 = 0%) versus Roadsaver/Casper 1.5% (0.7%–3.2%, I2 = 0%), p=0.30. The 30-day estimated stroke rate was 1.5% (0.8%–2.9%, I2 = 0%) in asymptomatic and 1.9% (1.0%–3.6%, I2 = 0%) in symptomatic patients, with no influence by moderators. The 30-day DLS occlusion rate was 0.8% (0.4%–1.8%, I2 = 0%). The publication bias assessment identified asymmetry in the asymptomatic populations. Conclusion: The overall 30-day stroke rate in CAS with DLS is low (1.4%), with similar results in symptomatic and asymptomatic patients. Acute occlusion of DLS is rare (0.8%). Further studies are necessary to reduce the publication bias for asymptomatic patients. Clinical Impact CAS with DLS is associated to a low rate of 30-day stroke in both symptomatic (1.9%) and asymptomatic (1.5%) patients. The type of DLS (CGuard or Roadsaver/Casper) did not affect the 30-day stroke rate.

show abstract

“Real-World Study of a Dual-Layer Micromesh Stent in Elective Treatment of Symptomatic and Asymptomatic Carotid Artery Stenosis (ROADSAVER)”

Cited by 8 publications

References 23 publications

Carotid artery interventions - endarterectomy versus stenting

Carotid artery interventions - endarterectomy versus stenting

One-Year Outcomes of CGuard Double Mesh Stent in Carotid Artery Disease: A Systematic Review and Meta-Analysis

Carotid Artery Stenting With Double-Layer Stent: A Systematic Review and Meta-Analysis

Contact Info

Product

Resources

About