Prospective Single Arm CAS - ROADSAVER Study

Launched by TERUMO EUROPE N.V. · Apr 19, 2018

Keywords

ClinConnect Summary

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. Baselin...

Gender

ALL

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