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| Name | Class |
|---|---|
| Complejo Hospitalario Toledo | OTHER |
| University Ghent | OTHER |
| Technical University of Munich | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients requiring carotid revascularization | Symptomatic patients, male or female, with atherosclerotic extracranial internal carotid stenosis (ICA) with or without involvement of the contiguous common artery (CCA), that require carotid revascularization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcarotid revascularization | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| New White Lesions | Incidence of new white lesions by DW-MRI post procedure. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Periprocedural SAEs | All stroke | 30 days |
| Periprocedural SAEs | All death | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients enrolled into this study will be comprised of male and female symptomatic patients requiring carotid revascularization.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Gent | Ghent | Belgium | ||||
| Technischen Universitat Munchen |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| post-procedure filter debris | filter debris morphology | 30 days |
| DW-MRI Lesions | Location of DW-MRI lesions | 30 days |
| DW-MRI Lesions | Volume of DW-MRI lesions | 30 days |
| Munich |
| Germany |
| Complejo Hospitalario de Toledo | Toledo | Spain |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |