MICHI™ Neuroprotection System (NPS+f) Filter Debris Analysis Study (The F-1 Study)
1 other identifier
observational
24
3 countries
6
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2013
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 27, 2013
CompletedFirst Posted
Study publicly available on registry
June 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedSeptember 3, 2014
September 1, 2014
5 months
May 27, 2013
September 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Volume of debris captured in the MICHI(TM) inline filter
During MICHI(TM) NPS+f procedure
Histological analysis of debris captured in the MICHI(TM) inline filter
During MICHI(TM) NPS+f procedure
Study Arms (1)
MICHI(TM) NPS+f
Patients routinely treated with the CE marked MICHI(TM) NPS+f System
Interventions
Transcarotid delivery system for carotid stents with flow reversal
Eligibility Criteria
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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University Hospital
Ghent, 9000, Belgium
Augusta Krankenhaus
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
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2013
First Posted
June 13, 2013
Study Start
May 1, 2013
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
September 3, 2014
Record last verified: 2014-09