An observational study in Internal Carotid Artery Stenosis, sponsored by Silk Road Medical. Completed at 6 sites in 3 countries. Per ClinicalTrials.gov, last updated 2014-09-03.
Sponsored by Silk Road Medical · Observational
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.
339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.
This study's enrollment of 24 is below the median of 173 across 144 observational studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →Silk Road Medical is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Inclusion and exclusion criteria per CE marked Instructions For Use
Inclusion Criteria:
Exclusion Criteria:
Patients routinely treated with the CE marked MICHI(TM) NPS+f System
Device: MICHI(TM) NPS+f · Procedure: transcarotid stenting
Transcarotid delivery system for carotid stents with flow reversal
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
Time frame: During MICHI(TM) NPS+f procedure
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
Time frame: During MICHI(TM) NPS+f procedure
Histological analysis of debris captured in the MICHI(TM) inline filter
For all patients, where debris is captured in the MICHI(TM) inline filter, the type of plaque will be determined.
Time frame: During MICHI(TM) NPS+f procedure
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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