Prospective Single Arm CAS - ROADSAVER Study

NCT ID: NCT03504228

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1967 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-23
• Study Completion Date: 2022-06-20

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.

Detailed Description

1. Baseline Assessments

The patient will be assessed in accordance with the hospital standard of care for patients treated with carotid artery stenting procedure, which in general includes:

• Informed consent for data collection
• Demographics
• Medical History
• Medication record
• Physical examination
• Carotid Duplex Ultrasound
• Neurological Assessment
• Diffusion weighted Magnetic Resonance Imaging (DW-MRI)
• Procedural angiography

Baseline assessments will be performed prior to the index procedure and documented in the patient medical record. Baseline assessments considered standard of care completed prior to obtaining informed consent do not need to be repeated unless the investigator feels it is medically necessary.

Neurological Assessment Baseline neurological assessment is recommended in this study and will be conducted by a physician, nurse, or other allied health professional, independent of the treating physician prior to the procedure. This assessment will include the neurological signs, symptoms, and the NIH Stroke Scale. For some pre-specified subgroups, imaging studies (Carotid Duplex Ultrasound and/or Diffusion Weighted Magnetic Resonance Imaging: DW-MRI) will be performed prior to the procedure.

2. Patient Enrollment Point A patient is considered enrolled in the study if there is full compliance with the study and RoadSaver IFU eligibility criteria, and only after successful guidewire passage through the study target lesion.

3. Medications Patients enrolled in this study will be pre-medicated according to the hospital routine practice.

4. Procedure The procedure will be performed according to the physician's standard of care. During the procedure, patients should receive appropriate anticoagulation and other therapy according to standard hospital practice. The use of any medication for the treatment of vessel spasm, patient agitation or discomfort, hypotension, arrhythmias, and hemodynamic changes during the procedure is at the discretion of the investigator.

Standard procedures should be followed based on the Instructions for Use for the Roadsaver™ device of Terumo. If pre- and/or post-dilatation is performed, or any other device (e.g. embolic protection devices, etc.) is used at the investigator's discretion.

4.1. Treatment Failures If a Roadsaver™ Carotid Stent is not implanted due to technical reasons, another CE-marked Carotid Stent may be used to complete the procedure. Patients who do not have a successful Roadsaver™ Carotid Stent implanted during the index procedure will be considered as technical failures.

Patients with technical failure will be followed only until discharge at which time they will have completed the study.

All patients who receive a Roadsaver™ Carotid Stent upon enrollment in the ROADSAVER study will be included in the analysis of clinical outcomes by the end of the study. Patients with technical failures will be analyzed separately only for procedural success and for in-hospital adverse events.

4.2. Device Deficiency and Device Malfunction A device deficiency is defined as an inadequacy of a medical device related to its identity, quality, durability, reliability, safety, or performance. This may include malfunctions, use error, or inadequacy in the information supplied by the manufacturer.

A device malfunction is defined as failure of the medical device to perform in accordance with its intended purpose when used in accordance with the instructions for use or the Clinical Investigation Plan.

In case of device deficiency or malfunction, the device deficiency form in the eCRF should be completed and the investigator is asked to make every possible effort to return the device to Terumo Europe accompanied if possible with the packaging containing the device identification (lot number). Another Roadsaver™ Carotid Stent or another stent as per operators' discretion will be used in order to complete the treatment of the patient.

5. Post-procedure

Post-procedural evaluation should be done according to the routine hospital practice prior to discharge, which in general includes:

• Post Angiography immediately after the index procedure
• Physical examination before discharge
• MAE defined as the cumulative incidence of any periprocedural death or stroke
• Adverse events including: any revascularization, major vascular and bleeding complications, other
• Medication
• Neurological assessment when performed
• Diffusion-weighted magnetic resonance imaging (DW-MRI) when performed

Information on the post-procedural evaluation and any interventional treatment that occurred since the procedure should be collected.

6. Follow-Up Evaluations Patients will be followed according to routine hospital practice usually performed at 30-day and at 12-month assessment through hospital visit or through telephone contact. Investigators and research coordinators will keep notes of all telephone contacts with the patients in the patient hospital file as source documents.

Hospital Visit at 1 month (30 ± 7 days) and 12 months (365 ± 30 days) Patients' clinical status should be reported if hospital visits are done at 30 days and 12 months.

These follow-up assessments should be done according to the routine hospital practice, which in general includes:

• Physical examination
• Adverse events including: any stroke, any Revascularization, major vascular and bleeding complications, other
• Medication
• Neurological assessment
• Carotid duplex ultrasound
• Diffusion-weighted magnetic resonance imaging (DW-MRI)

All relevant information obtained during follow-up including imaging should be reported. Data to be collected at follow-ups would include:

Telephone Contact at 12 months (365 ±30 days)

• Adverse Events including: any death (stroke related/other), any stroke, any revascularization, major vascular and bleeding complications, other
• Medication In case of death, stroke, TLR, and TVR all efforts should be made to provide sufficient baseline and event documentation.

Unscheduled Follow-Up

The assessment at unscheduled visits should be performed according to safety reporting requirements, which in general includes:

• Physical examination
• Adverse events including: any stroke, any revascularization, major vascular and bleeding complications, other
• Medication
• Neurological assessment
• Carotid duplex ultrasound
• Diffusion-weighted magnetic resonance imaging (DW-MRI)

A patient who returns to the investigational site between pre-determined visits with an event related to the index procedure should be treated according to the physician's standard of care. Reportable events occurring during this period should be collected.

Conditions

Carotid Artery Stenosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Roadsaver

Dual layer micromesh Roadsaver carotid stent

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Any condition that makes patient unsuitable for percutaneous transluminal angioplasty (PTA), including intolerance or allergy to any material used and accompanying therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terumo Europe N.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ihsen Merioua, MD

Role: STUDY_DIRECTOR

Ihsen.Merioua@terumo-europe.com

Locations

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

Countries

Belgium; Czechia; France; Germany; Hungary; Latvia; Netherlands; North Macedonia; Poland; Portugal; Serbia; Slovakia; Spain

References

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.

Reference Type: DERIVED

PMID: 40220262 (View on PubMed)

Kedev 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.

Reference Type: DERIVED

PMID: 35043241 (View on PubMed)

Other Identifiers

T130E2

Identifier Type: -

Identifier Source: org_study_id