Prospective Single Arm CAS - ROADSAVER Study

Carotid Artery Stenosis Clinical Trial

— ROADSAVER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504228
• Other study ID #: T130E2
• Status: Completed
• Start date: January 23, 2018
• Est. completion date: June 20, 2022

Study information

• Verified date: January 2023
• Source: Terumo Europe N.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1967
• Est. completion date: June 20, 2022
• Est. primary completion date: February 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic

Intervention

Device:
• Roadsaver
Dual layer micromesh Roadsaver carotid stent

Locations

Country	Name	City	State
Belgium	OLV Ziekenhuis	Aalst
Belgium	Imelda Ziekenhuis	Bonheiden
Belgium	AZ Sint-Blasius	Dendermonde
Belgium	AZ Groeninge	Kortrijk
Belgium	UZ Leuven	Leuven
Czechia	University Hospital Ostrava	Ostrava
Czechia	Central Military Hospital Prague	Prague
France	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
Germany	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/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
Hungary	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
Latvia	Paul Stradins Clinical University Hospital	Riga
Netherlands	UMC Groningen	Groningen
Netherlands	Sint-Antonius Ziekenhuis	Nieuwegein
North Macedonia	City General Hospital 8th September Skopje	Skopje
North Macedonia	University Clinic of Cardiology	Skopje
Poland	Szpital Uniwersytecki nr.2 im. Dr J. Biziela w Bydgoszczy	Bydgoszcz
Poland	Krakowski Szpital Specjalistyczny im. Jana Pawla II	Kraków
Poland	Szpital Uniwersytecki w Krakowie	Kraków
Portugal	Centro Hospitalar Vilanova Gaia/Espinho	Vila Nova De Gaia
Serbia	ICVD Dedinje	Belgrad
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Clinical Center of Vojvodina	Novi Sad
Slovakia	Cinre S.R.O.	Bratislava
Slovakia	Kardiocentrum Nitra	Nitra
Spain	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	Tenerife
Spain	Hospital Virgen de La Salud de Toledo	Toledo
Spain	Hospital Universitario Clínico de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Terumo Europe N.V.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Any death (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)	Adjudicated by an independent Clinical Events Committee.	Up to 12 months
Other	Stroke-related death (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)	Adjudicated by an independent Clinical Events Committee.	Up to 12 months
Other	Any stroke (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)	Defined as an acute neurologic event with focal symptoms and signs, lasting for 24 hours or more, adjudicated by an independent Clinical Events Committee.	Up to 12 months
Other	Ipsilateral stroke (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)	Defined as a stroke occurring within the vascular distribution of the stented artery, adjudicated by an independent Clinical Events Committee.	Up to 12 months
Other	Target lesion revascularization (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)	Defined as any revascularization procedure of the original treatment site, including angioplasty, stenting, endarterectomy, or thrombolysis, performed to open or increase the luminal diameter inside or within 5 mm of the previously treated lesion (Adjudicated by an independent clinical events committee).	Up to 12 months
Other	In-stent restenosis (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)	Measured within the stented lesion or within 5 mm proximal or distal to the stent, defined as =50% stenosis by ultrasound (Peak Systolic Velocity Ratio (PSVR; PSV(ICA) / PSV(CCA) >2) or = 70% stenosis by angiography).	Up to 12 months
Other	External carotid artery patency (Rate assessed in a subgroup of patients that undergoes 12-month follow-up as per standard of care)	Determined as per ultrasound assessment	Up to 12 months
Primary	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	Technical Success	Defined as a successful access and deployment of the device with recanalization, determined by <30% residual stenosis by angiography during the index procedure.	Peri-procedural
Secondary	Procedural success	Defined as technical success with no device-/procedure-related death, stroke or any other serious adverse events.	Peri-procedural
Secondary	Device malfunction	Defined as the failure of a device after its introduction into the patient (i.e. failure to perform in accordance with its intended purpose when used as per the Instructions For Use or the Clinical Investigation Plan).	Peri-procedural
Secondary	Any death	Adjudicated by an independent Clinical Events Committee.	Up to 30 days
Secondary	Stroke-related death	Defined as a death which has been adjudicated by an independent clinical events committee to have directly resulted from a stroke.	Up to 30 days
Secondary	Any stroke	Defined as an acute neurologic event with focal symptoms and signs, lasting for 24 hours or more (Adjudicated by an independent Clinical Events Committee).	Up to 30 days
Secondary	Major stroke	Defined as a new neurological event that persists for > 24 hours and results in a > 4 point increase in the NIHSS score relative to baseline or any subsequent lower score (Adjudicated by an independent Clinical Events Committee).	Up to 30 days
Secondary	Minor stroke	Defined as a new neurological event that resolves completely within 7 days or increases the NIHSS by =4 points (Adjudicated by an independent Clinical Events Committee).	Up to 30 days
Secondary	Transient ischemic attack	TIA	Up to 30 days
Secondary	Target lesion revascularization (TLR)	Defined as any revascularization procedure of the original treatment site, including angioplasty, stenting, endarterectomy, or thrombolysis, performed to open or increase the luminal diameter inside or within 5 mm of the previously treated lesion (Adjudicated by an independent clinical events committee).	Up to 30 days
Secondary	Major vascular and bleeding complications:	Major hematoma, i.e. one requiring transfusion, surgical evacuation, or delay in discharge,; Pseudo aneurysm or arteriovenous fistula or retroperitoneal bleeding,; Peripheral ischemia/nerve injury caused by the proximal access site,; Vascular surgical repair to correct a local vascular access site complication and bleeding.	Up to 30 days