Trials / Completed
CompletedNCT01877174
MICHI™ Neuroprotection System (NPS+f) Filter Debris Analysis Study (The F-1 Study)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 24 (actual)
- Sponsor
- Silk Road Medical · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MICHI(TM) NPS+f | Transcarotid delivery system for carotid stents with flow reversal |
| PROCEDURE | transcarotid stenting |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2013-10-01
- Completion
- 2013-10-01
- First posted
- 2013-06-13
- Last updated
- 2014-09-03
Locations
6 sites across 3 countries: Belgium, Germany, Spain
Source: ClinicalTrials.gov record NCT01877174. Inclusion in this directory is not an endorsement.