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This study will be conducted in up to 10 hospitals in Europe, up to 75 patients will be enrolled. The purpose of the study is to evaluate any debris that may be captured in the inline filter of the MICHI(TM) Neuroprotection System with Filter (NPS+f) during its use in a transcarotid stenting procedure. The MICHI NPS+f is an embolic protection device that uses reverse flow to protect the brain during stenting of the Internal Carotid Artery. It is CE marked and is used in routine practice for the purpose of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MICHI(TM) NPS+f | Patients routinely treated with the CE marked MICHI(TM) NPS+f System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MICHI(TM) NPS+f | Device | Transcarotid delivery system for carotid stents with flow reversal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with debris captured in the MICHI(TM) inline filter | The percentage of patients with any debris captured in the MICHI(TM) inline filter will be calculated | During MICHI(TM) NPS+f procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of debris captured in the MICHI(TM) inline filter | For all patients, where debris is captured in the MICHI(TM) inline filter, the volume of debris will be measured | During MICHI(TM) NPS+f procedure |
| Histological analysis of debris captured in the MICHI(TM) inline filter |
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Inclusion and exclusion criteria per CE marked Instructions For Use
Inclusion Criteria:
Exclusion Criteria:
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Patients who are booked for a routine stenting of the Internal Carotid Artery (bifurcation may be involved) using the MICHI(TM) NPS+f System, at vascular surgery departments or interventional radiology departments
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Ghent | 9000 | Belgium | |||
| Augusta Krankenhaus |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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The inline filter of the MICHI(TM) NPS+f System may contain debris that is released from the lesion during carotid stenting. It is the objective of the study to determine the volume and characteristics of the debris.
| transcarotid stenting | Procedure |
|
For all patients, where debris is captured in the MICHI(TM) inline filter, the type of plaque will be determined. |
| During MICHI(TM) NPS+f procedure |
| Düsseldorf |
| 40472 |
| Germany |
| University Hospital Son Espases | Palma | Mallorca | 07120 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Medico Quirurgic | Jaén | 23007 | Spain |
| Complejo Hospitalario de Toledo | Toledo | 45004 | Spain |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |