Status:
COMPLETED
MICHI™ Neuroprotection System (NPS+f) Filter Debris Analysis Study (The F-1 Study)
Lead Sponsor:
Silk Road Medical
Conditions:
Internal Carotid Artery Stenosis
Eligibility:
All Genders
Brief 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 MI...
Eligibility Criteria
Inclusion
- Inclusion and exclusion criteria per CE marked Instructions For Use
- Adequate central venous access
- Common carotid artery reference diameter of at least 6 mm
- Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography
Exclusion
- Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated
- Patients with unresolved bleeding disorders
- Patients with severe disease of the ipsilateral common carotid artery
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01877174
Start Date
May 1 2013
End Date
October 1 2013
Last Update
September 3 2014
Active Locations (6)
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1
University Hospital
Ghent, Belgium, 9000
2
Augusta Krankenhaus
Düsseldorf, Germany, 40472
3
University Hospital Son Espases
Palma, Mallorca, Spain, 07120
4
Hospital Vall d'Hebron
Barcelona, Spain, 08035