Clinical trial NCT03504228: Prospective Single Arm CAS - ROADSAVER Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Artery Stenosis
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
First posted: 2018-04-20
Enrollment: 1967
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients included in this study will be comprised of male and female patients derived from general interventional radiology or angiology populations.

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.

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

Primary outcomes:
measure: The rate of Major Adverse Events (MAE)
timeFrame: Up to 30 days
Secondary outcomes:
measure: Technical Success
timeFrame: Peri-procedural
measure: Procedural success
timeFrame: Peri-procedural
measure: Device malfunction
timeFrame: Peri-procedural
measure: Any death
timeFrame: Up to 30 days
measure: Stroke-related death
timeFrame: Up to 30 days
measure: Any stroke
timeFrame: Up to 30 days
measure: Major stroke
timeFrame: Up to 30 days
measure: Minor stroke
timeFrame: Up to 30 days
measure: Transient ischemic attack
timeFrame: Up to 30 days
measure: Target lesion revascularization (TLR)
timeFrame: Up to 30 days
measure: Major vascular and bleeding complications:
timeFrame: Up to 30 days
Other outcomes:
measure: Any death (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)
timeFrame: Up to 12 months
measure: Stroke-related death (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)
timeFrame: Up to 12 months
measure: Any stroke (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)
timeFrame: Up to 12 months
measure: Ipsilateral stroke (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)
timeFrame: Up to 12 months
measure: Target lesion revascularization (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)
timeFrame: Up to 12 months
measure: In-stent restenosis (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)
timeFrame: Up to 12 months
measure: External carotid artery patency (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)
timeFrame: Up to 12 months
Locations:
city: Aalst
country: Belgium
facility: OLV Ziekenhuis
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Prague
country: Czechia
facility: Central Military Hospital Prague
city: Bayonne
country: France
facility: GCS Centre de Cardiologie du Pays Basque
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble
city: Marseille
country: France
facility: Hopital de la Timone 2
city: Nancy
country: France
facility: Polyclinique Louis Pasteur Essey Les Nancy
city: Berlin
country: Germany
facility: Ihre-Radiologen.de
city: Berlin
country: Germany
facility: Sankt-Gertrauden Krankenhaus
city: Bruchsal
country: Germany
facility: Fürst-Stirum-Klinik
city: Flensburg
country: Germany
facility: Diakonissenkrankenhaus Flensburg Ev.-Luth. Diakonissenanstalt zu Flensburg
city: Frankfurt/Main
country: Germany
facility: Cardioangiological Center Bethanien
city: Karlsbad
country: Germany
facility: SRK Karlsbad
city: Mannheim
country: Germany
facility: Theresienkrankenhaus Mannheim
city: Münster
country: Germany
facility: St. Franziskus-Hospital Münster
city: Oldenburg
country: Germany
facility: Pius Hospital Oldenburg
city: Passau
country: Germany
facility: Klinikum Passau
city: Radebeul
country: Germany
facility: Elblandklinikum Radebeul
city: Suhl
country: Germany
facility: SRH Zentralklinikum Suhl
city: Ulm
country: Germany
facility: Universitäts und Rehabilitationskliniken Ulm
city: Budapest
country: Hungary
facility: Markusovszky Teaching Hospital
city: Budapest
country: Hungary
facility: Semmelweis University Heart and Vascular Center
city: Kaposvár
country: Hungary
facility: Moritz Kaposi Teaching Hospital
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun County Hospital
city: Pécs
country: Hungary
facility: University of Pécs
city: Szeged
country: Hungary
facility: Szeged University Hospital
city: Székesfehérvár
country: Hungary
facility: Szent György Fejér County - University Teaching Hospital
city: Riga
country: Latvia
facility: Paul Stradins Clinical University Hospital
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Nieuwegein
country: Netherlands
facility: Sint-Antonius Ziekenhuis
city: Skopje
country: North Macedonia
facility: City General Hospital 8th September Skopje
city: Skopje
country: North Macedonia
facility: University Clinic of Cardiology
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr.2 im. Dr J. Biziela w Bydgoszczy
city: Kraków
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar Vilanova Gaia/Espinho
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrad
country: Serbia
facility: ICVD Dedinje
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina
city: Bratislava
country: Slovakia
facility: Cinre S.R.O.
city: Nitra
country: Slovakia
facility: Kardiocentrum Nitra
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Barcelona
country: Spain
facility: Hospital Clinico de Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebron
city: Girona
country: Spain
facility: Hospital Universitario Girona Josep Trueta
city: Jaén
country: Spain
facility: Complejo Hospitalario De Jaen
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Marbella
country: Spain
facility: Hospital Quironsalud Marbella
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
city: Tenerife
country: Spain
facility: Hospital universitario de Canarias
city: Toledo
country: Spain
facility: Hospital Virgen de La Salud de Toledo
city: Valladolid
country: Spain
facility: Hospital Universitario Clínico de Valladolid
Study officials:
affiliation: Ihsen.Merioua@terumo-europe.com
name: Ihsen Merioua, MD
role: STUDY_DIRECTOR
References:
citation: 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.