The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions (relative to baseline) and debris captured in the ENROUTE Transcarotid NPS inline filter during a transcarotid stenting procedure.
The ENROUTE Transcarotid NPS has received CE Mark and is commercially available in the European Union. The ENROUTE Transcarotid NPS may be used in conjunction with carotid artery stent approved for revascularization in patients with carotid disease in the context of this study. This is a prospective, single-arm, multi-center clinical trial of the ENROUTE Transcarotid NPS in conjunction with all commercially approved carotid artery stents used for revascularization in patients with carotid disease. The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions (relative to baseline) and debris captured in the ENROUTE Transcarotid NPS inline filter during a transcarotid stenting procedure. A patient is considered enrolled after: 1. meeting all inclusion and none of the exclusion criteria, 2. the transcarotid arterial sheath has entered into the patient's vasculature. Insertion of the venous sheath does not qualify a patient as enrolled. Patients who are screened but do not meet all study criteria are considered screen failures and may not be enrolled. Patients in whom an arterial sheath is placed but who do not meet all study entry criteria are considered enrolled. The Investigator is responsible for maintaining any information pertaining to the Ethics Committee review and approval as required by local law.
Study Type
OBSERVATIONAL
Enrollment
31
The ENROUTE Transcarotid Neuroprotection System (NPS) has received CE Mark and is commercially available in the European Union. The ENROUTE Transcarotid NPS may be used in conjunction with carotid artery stent approved for revascularization in patients with carotid disease The ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis
Universitair Ziekenhuis Gent
Ghent, Belgium
Technischen Universitat Munchen
Munich, Germany
Complejo Hospitalario de Toledo
Toledo, Spain
New White Lesions
Incidence of new white lesions by DW-MRI post procedure.
Time frame: 30 days
Periprocedural SAEs
All stroke
Time frame: 30 days
Periprocedural SAEs
All death
Time frame: 30 days
post-procedure filter debris
filter debris morphology
Time frame: 30 days
DW-MRI Lesions
Location of DW-MRI lesions
Time frame: 30 days
DW-MRI Lesions
Volume of DW-MRI lesions
Time frame: 30 days
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