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

Internal Carotid Artery Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877174
• Other study ID #: SRM-2013-01
• Status: Completed
• Phase: N/A
• First received: May 27, 2013
• Last updated: September 2, 2014
• Start date: May 2013
• Est. completion date: October 2013

Study information

• Verified date: September 2014
• Source: Silk Road Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion and exclusion criteria per CE marked Instructions For Use

Inclusion Criteria:

1. Adequate central venous access

2. Common carotid artery reference diameter of at least 6 mm

3. 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 Criteria:

1. Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated

2. Patients with unresolved bleeding disorders

3. Patients with severe disease of the ipsilateral common carotid artery

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Carotid Stenosis
• Internal Carotid Artery Stenosis

Intervention

Device:
• MICHI(TM) NPS+f
Transcarotid delivery system for carotid stents with flow reversal

Procedure:
• transcarotid stenting

Locations

Country	Name	City	State
Belgium	University Hospital	Gent
Germany	Augusta Krankenhaus	Duesseldorf
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Medico Quirurgic	Jaen
Spain	University Hospital Son Espases	Palma	Mallorca
Spain	Complejo Hospitalario de Toledo	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
Silk Road Medical

Countries where clinical trial is conducted

Belgium,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	During MICHI(TM) NPS+f procedure	No
Secondary	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.	During MICHI(TM) NPS+f procedure	No