Prospective Single Arm CAS - ROADSAVER Study
ROADSAVER
Prospective, Single-arm, Multi-center, Observational Study to Further Confirm Safety and Efficacy of the Dual-layer Micromesh Roadsaver Stent for the Treatment of Carotid Artery Stenosis in Patients Eligible for Elective Stenting Procedure
1 other identifier
observational
1,967
13 countries
57
Brief Summary
Approximately 2000 patients eligible for elective treatment with a Carotid Stent according to hospital routine practice in centers across Europe will be enrolled in the study. The maximum number of patients enrolled at each site will be not limited. Follow-ups are scheduled at discharge, 30 days, and 1 year, as per local practice. Each patient will have follow-up contacts via hospital visit and/or telephone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 23, 2018
CompletedFirst Submitted
Initial submission to the registry
March 15, 2018
CompletedFirst Posted
Study publicly available on registry
April 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2022
CompletedMarch 21, 2023
January 1, 2023
3.1 years
March 15, 2018
March 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The rate of Major Adverse Events (MAE)
Defined as the cumulative incidence of any death or stroke up to 30 days after the index procedure.
Up to 30 days
Secondary Outcomes (11)
Technical Success
Peri-procedural
Procedural success
Peri-procedural
Device malfunction
Peri-procedural
Any death
Up to 30 days
Stroke-related death
Up to 30 days
- +6 more secondary outcomes
Other Outcomes (7)
Any death (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)
Up to 12 months
Stroke-related death (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)
Up to 12 months
Any stroke (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)
Up to 12 months
- +4 more other outcomes
Interventions
Dual layer micromesh Roadsaver carotid stent
Eligibility Criteria
Patients included in this study will be comprised of male and female patients derived from general interventional radiology or angiology populations.
You may qualify if:
- The patient has a non-occlusive and non-thrombotic carotid artery stenosis and is eligible to be treated with Roadsaver Carotid Stent as per the Instructions for Use (IFU)
- The patient is at least 18 years of age
- The patient has a life expectancy of at least 12 months from the date of the index procedure
- The patient is able and willing to provide a signed IRB-/EC-approved informed consent form prior to participation
You may not qualify if:
- \- Any condition that makes patient unsuitable for percutaneous transluminal angioplasty (PTA), including intolerance or allergy to any material used and accompanying therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
OLV Ziekenhuis
Aalst, Belgium
Imelda Ziekenhuis
Bonheiden, Belgium
AZ Sint-Blasius
Dendermonde, Belgium
AZ Groeninge
Kortrijk, Belgium
UZ Leuven
Leuven, Belgium
University Hospital Ostrava
Ostrava, Czechia
Central Military Hospital Prague
Prague, Czechia
GCS Centre de Cardiologie du Pays Basque
Bayonne, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France
Hopital de la Timone 2
Marseille, France
Polyclinique Louis Pasteur Essey Les Nancy
Nancy, France
Ihre-Radiologen.de
Berlin, Germany
Sankt-Gertrauden Krankenhaus
Berlin, Germany
Fürst-Stirum-Klinik
Bruchsal, Germany
Diakonissenkrankenhaus Flensburg Ev.-Luth. Diakonissenanstalt zu Flensburg
Flensburg, Germany
Cardioangiological Center Bethanien
Frankfurt am Main, Germany
SRK Karlsbad
Karlsbad, Germany
Theresienkrankenhaus Mannheim
Mannheim, Germany
St. Franziskus-Hospital Münster
Münster, Germany
Pius Hospital Oldenburg
Oldenburg, Germany
Klinikum Passau
Passau, Germany
Elblandklinikum Radebeul
Radebeul, Germany
SRH Zentralklinikum Suhl
Suhl, Germany
Universitäts und Rehabilitationskliniken Ulm
Ulm, Germany
Markusovszky Teaching Hospital
Budapest, Hungary
Semmelweis University Heart and Vascular Center
Budapest, Hungary
Moritz Kaposi Teaching Hospital
Kaposvár, Hungary
Bacs-Kiskun County Hospital
Kecskemét, Hungary
University of Pécs
Pécs, Hungary
Szeged University Hospital
Szeged, Hungary
Szent György Fejér County - University Teaching Hospital
Székesfehérvár, Hungary
Paul Stradins Clinical University Hospital
Riga, Latvia
UMC Groningen
Groningen, Netherlands
Sint-Antonius Ziekenhuis
Nieuwegein, Netherlands
City General Hospital 8th September Skopje
Skopje, North Macedonia
University Clinic of Cardiology
Skopje, North Macedonia
Szpital Uniwersytecki nr.2 im. Dr J. Biziela w Bydgoszczy
Bydgoszcz, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, Poland
Szpital Uniwersytecki w Krakowie
Krakow, Poland
Centro Hospitalar Vilanova Gaia/Espinho
Vila Nova de Gaia, Portugal
Clinical Center of Serbia
Belgrade, Serbia
ICVD Dedinje
Belgrade, Serbia
Clinical Center of Vojvodina
Novi Sad, Serbia
Cinre S.R.O.
Bratislava, Slovakia
Kardiocentrum Nitra
Nitra, Slovakia
Hospital Universitario A Coruña
A Coruña, Spain
Hospital Clinico de Barcelona
Barcelona, Spain
Hospital Vall D'Hebron
Barcelona, Spain
Hospital Universitario Girona Josep Trueta
Girona, Spain
Complejo Hospitalario De Jaen
Jaén, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Quironsalud Marbella
Marbella, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Spain
Hospital Universitario Donostia
San Sebastián, Spain
Hospital universitario de Canarias
Santa Cruz de Tenerife, Spain
Hospital Virgen de La Salud de Toledo
Toledo, Spain
Hospital Universitario Clínico de Valladolid
Valladolid, Spain
Related Publications (2)
Muller-Hulsbeck S, Vajda Z, Odrowaz-Pieniazek P, Ruzsa Z, Beelen R, Gjoreski A, Deloose K, Castro S, Faurie B, Tomasello Weitz A, Schwindt A, Latacz P, Orgaz Perez-Grueso A, Cvetic V, Langhoff R, Kedev S; all ROADSAVER study investigators. Contemporary carotid artery stenting practices and peri-procedural outcomes in different European countries: ROADSAVER study multicentric insights. CVIR Endovasc. 2025 Apr 12;8(1):29. doi: 10.1186/s42155-025-00528-z.
PMID: 40220262DERIVEDKedev S, Muller-Hulsbeck S, Langhoff R. "Real-World Study of a Dual-Layer Micromesh Stent in Elective Treatment of Symptomatic and Asymptomatic Carotid Artery Stenosis (ROADSAVER)". Cardiovasc Intervent Radiol. 2022 Mar;45(3):277-282. doi: 10.1007/s00270-021-03051-5. Epub 2022 Jan 18.
PMID: 35043241DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ihsen Merioua, MD
Ihsen.Merioua@terumo-europe.com
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2018
First Posted
April 20, 2018
Study Start
January 23, 2018
Primary Completion
February 18, 2021
Study Completion
June 20, 2022
Last Updated
March 21, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share