Internal Carotid Artery StenosisNCT01877174
MICHI™ Neuroprotection System (NPS+f) Filter Debris Analysis Study (The F-1 Study)
An observational study of Internal Carotid Artery Stenosis, run by Silk Road Medical at 6 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Internal Carotid Artery Stenosis
- What is being tested?
- MICHI(TM) NPS+f and transcarotid stenting
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 24 participants
- Where
- 6 sitesin 3 countries
- Study dates
- May 2013to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Spain4 sites
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Medico Quirurgic
Jaén, 23007
University Hospital Son Espases
Palma, Mallorca, 07120
Complejo Hospitalario de Toledo
Toledo, 45004
About this study
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
- Internal Carotid Artery Stenosis
- Being tested
- MICHI(TM) NPS+f, transcarotid stenting
- Keywords
- Internal Carotid Stenosis, Reverse Flow, Carotid stenting, MICHI(TM) NPS+f
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICHI(TM) NPS+fDevice
Transcarotid delivery system for carotid stents with flow reversal
transcarotid stentingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| MICHI(TM) NPS+f | Patients routinely treated with the CE marked MICHI(TM) NPS+f System Receives: Device: MICHI(TM) NPS+f; Procedure: transcarotid stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During MICHI(TM) NPS+f procedure
Secondary outcomes (2)
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
Measured: During MICHI(TM) NPS+f procedure
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.
Measured: During MICHI(TM) NPS+f procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal Carotid Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silk Road Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877174
- Sponsor's protocol ID
- SRM-2013-01
- Status last verified
- Sep 2014
- First submitted
- 27 May 2013
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MICHI™ Neuroprotection System (NPS+f) Filter Debris Analysis Study (The F-1 Study)
- ClinicalTrials.gov ID
- NCT01877174
- Acronym / sponsor ID
- SRM-2013-01
- Conditions
- Internal Carotid Artery Stenosis
- Keywords
- Internal Carotid Stenosis, Reverse Flow, Carotid stenting, MICHI(TM) NPS+f
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Silk Road MedicalIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MICHI(TM) NPS+f | – | Device: MICHI(TM) NPS+f, Procedure: transcarotid stentingPatients routinely treated with the CE marked MICHI(TM) NPS+f System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MICHI(TM) NPS+fTranscarotid delivery system for carotid stents with flow reversal | Device | MICHI(TM) NPS+f |
| transcarotid stenting | Procedure or surgery | MICHI(TM) NPS+f |
Primary outcome
Percentage of patients with debris captured in the MICHI(TM) inline filter
Time frame: During MICHI(TM) NPS+f procedure
The percentage of patients with any debris captured in the MICHI(TM) inline filter will be calculated
2 secondary outcomes
Volume of debris captured in the MICHI(TM) inline filter
Time frame: During MICHI(TM) NPS+f procedure
Histological analysis of debris captured in the MICHI(TM) inline filter
Time frame: During MICHI(TM) NPS+f procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Internal Carotid Artery Stenosis, run by Silk Road Medical at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with debris captured in the MICHI(TM) inline filter (time frame: During MICHI(TM) NPS+f procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2014.