CompletedNot Applicable

MICHI™ Neuroprotection System (NPS+f) Filter Debris Analysis Study (The F-1 Study)

Belgium, Germany, Spain24 participantsStarted 2013-05

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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
✕. 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

What they're measuring

Percentage of patients with debris captured in the MICHI(TM) inline filter

Timeframe: During MICHI(TM) NPS+f procedure

Trial details

NCT IDNCT01877174

SponsorSilk Road Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-10

View on ClinicalTrials.gov More Internal Carotid Artery Stenosis trials