Last updated on January 2020

Observational Study to Confirm Safety and Efficacy of the ROADSAVER Stent for the Treatment of Carotid Artery Stenosis

Brief description of study

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 Study 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. Postprocedure

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.

Clinical Study Identifier: NCT03504228

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Recruitment Status: Open

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