Carotid StenosisNCT02915328
Role of the Type of Carotid Stent and Cerebral Protection on Cerebral Microembolization During Carotid Artery Stenting. A Randomized Study Comparing Carotid Wallstent vs Roadsaver® Stent and Distal vs Proximal Protection.
A study testing Filterwire EZ™, MO.MA Ultra and Stent Roadsaver® in people with Carotid Stenosis, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The intra and/or postprocedural cerebral embolization remains the most frequent complication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Filterwire EZ™, MO.MA Ultra and Stent Roadsaver®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2016to Apr 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- significant, unilateral carotid artery stenosis with soft plaque defined as:
- symptomatic patients: > 1.3 m/sec peak systolic velocity and > 50% diameter stenosis by Doppler ultrasound and < 60 hounsfield unit by CT angiography
- asymptomatic patients > 2.5 m/sec peak systolic velocity and > 70% diameter stenosis by Doppler ultrasound and < 60 hounsfield unit by CT angiography
Who cannot join
- severe cerebral vasculopathy with cognitive impairment
- contraindication to double antiplatelet treatment
- controlateral carotid occlusion
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Centro Cardiologico Monzino, IRCCS
Milan, MI, 20138
Piero Montorsi, MD, 0038 0258002 ext. 576
Stefano Galli, MD, 0038 0258002 ext. 533
About this study
Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The intra and/or postprocedural cerebral embolization remains the most frequent complication.
The type of carotid stent and of cerebral protection are the two most important variables potentially affecting the rate of cerebral microembolization. So far there no consensus on the the best stent and cerebral protection.
- Conditions
- Carotid Stenosis
- Being tested
- Filterwire EZ™, MO.MA Ultra, Stent Roadsaver®, Carotid Wallstent
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filterwire EZ™Device
MO.MA UltraDevice
Stent Roadsaver®Device
Carotid WallstentDevice
| Study group | Role | What they receive |
|---|---|---|
| Stent Roadsaver® +Filterwire EZ™ | Experimental | The arm assess the efficacy of the combination of the stent Roadsaver® with the Filterwire EZ™ protection Receives: Device: Filterwire EZ™; Device: Stent Roadsaver® |
| Stent Roadsaver® + MO.MA Ultra | Experimental | The arm assess the efficacy of the combination of the stent Roadsaver® with the MO.MA Ultra protection Receives: Device: MO.MA Ultra; Device: Stent Roadsaver® |
| Carotid Wallstent +MO.MA Ultra | Experimental | The arm assess the efficacy of the combination of the Carotid Wallstent with the MO.MA Ultra protection Receives: Device: MO.MA Ultra; Device: Carotid Wallstent |
| Carotid Wallstent + Filterwire EZ™ | Experimental | The arm assess the efficacy of the combination of the Carotid Wallstent with the Filterwire EZ™ protection Receives: Device: Filterwire EZ™; Device: Carotid Wallstent |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of microembolization signals (MES) detected with transcranial doppler
different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device retrieval/deflation
Measured: intraprocedural
Secondary outcomes (3)
Clinical success
all strokes, major and minor strokes, myocardial infarction
Measured: day 2 or day 3 and day 30 complication
6 month clinical follow up
all strokes, major and minor strokes, myocardial infarction
Measured: 6 month
Doppler ultrasound assesment
stent patency and long term restenosis of target carotid artery and target vessel external carotid artery
Measured: day 2 or day 3, 1 month and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piero Montorsi, Centro Cardiologico Monzino
- Investigators
- Piero Montorsi, MD, Principal investigator, Centro Cardiologico Monzino, IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915328
- Sponsor's protocol ID
- R323/15 - CCM334
- Status last verified
- Sep 2016
- First submitted
- 20 Sep 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Montorsi P, Caputi L, Galli S, Ravagnani PM, Teruzzi G, Annoni A, Calligaris G, Fabbiocchi F, Trabattoni D, de Martini S, Grancini L, Pontone G, Andreini D, Troiano S, Restelli D, Bartorelli AL. Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting. JACC Cardiovasc Interv. 2020 Feb 24;13(4):403-414. doi: 10.1016/j.jcin.2019.09.007. Epub 2020 Jan 29.
PubMed 32007460
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Type of Carotid Stent and Cerebral Protection on Cerebral Microembolization During Carotid Artery Stenting. A Randomized Study Comparing Carotid Wallstent vs Roadsaver® Stent and Distal vs Proximal Protection.
- ClinicalTrials.gov ID
- NCT02915328
- Acronym / sponsor ID
- R323/15 - CCM334
- Conditions
- Carotid Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 27 Sep 2016 (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.
Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The intra and/or postprocedural cerebral embolization remains the most frequent complication.
The type of carotid stent and of cerebral protection are the two most important variables potentially affecting the rate of cerebral microembolization. So far there no consensus on the the best stent and cerebral protection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stent Roadsaver® +Filterwire EZ™ | Experimental | Device: Filterwire EZ™, Device: Stent Roadsaver®The arm assess the efficacy of the combination of the stent Roadsaver® with the Filterwire EZ™ protection |
| Stent Roadsaver® + MO.MA Ultra | Experimental | Device: MO.MA Ultra, Device: Stent Roadsaver®The arm assess the efficacy of the combination of the stent Roadsaver® with the MO.MA Ultra protection |
| Carotid Wallstent +MO.MA Ultra | Experimental | Device: MO.MA Ultra, Device: Carotid WallstentThe arm assess the efficacy of the combination of the Carotid Wallstent with the MO.MA Ultra protection |
| Carotid Wallstent + Filterwire EZ™ | Experimental | Device: Filterwire EZ™, Device: Carotid WallstentThe arm assess the efficacy of the combination of the Carotid Wallstent with the Filterwire EZ™ protection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- symptomatic patients: > 1.3 m/sec peak systolic velocity and > 50% diameter stenosis by Doppler ultrasound and < 60 hounsfield unit by CT angiography
- asymptomatic patients > 2.5 m/sec peak systolic velocity and > 70% diameter stenosis by Doppler ultrasound and < 60 hounsfield unit by CT angiography
Key exclusion criteria (3 listed)
- severe cerebral vasculopathy with cognitive impairment
- contraindication to double antiplatelet treatment
- controlateral carotid occlusion
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 |
|---|---|---|
| Filterwire EZ™ | Device | Carotid Wallstent + Filterwire EZ™, Stent Roadsaver® +Filterwire EZ™ |
| MO.MA Ultra | Device | Carotid Wallstent +MO.MA Ultra, Stent Roadsaver® + MO.MA Ultra |
| Stent Roadsaver® | Device | Stent Roadsaver® + MO.MA Ultra, Stent Roadsaver® +Filterwire EZ™ |
| Carotid Wallstent | Device | Carotid Wallstent + Filterwire EZ™, Carotid Wallstent +MO.MA Ultra |
Primary outcome
number of microembolization signals (MES) detected with transcranial doppler
Time frame: intraprocedural
different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device retrieval/deflation
3 secondary outcomes
Clinical success
Time frame: day 2 or day 3 and day 30 complication
6 month clinical follow up
Time frame: 6 month
Doppler ultrasound assesment
Time frame: day 2 or day 3, 1 month and 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Derived from this study: PubMed 32007460Montorsi P, Caputi L, Galli S, Ravagnani PM, Teruzzi G, Annoni A, Calligaris G, Fabbiocchi F, Trabattoni D, de Martini S, Grancini L, Pontone G, Andreini D, Troiano S, Restelli D, Bartorelli AL. Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting. JACC Cardiovasc Interv. 2020 Feb 24;13(4):403-414. doi: 10.1016/j.jcin.2019.09.007. Epub 2020 Jan 29.
- Individual participant dataSharing planned: No
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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.
Piero Montorsi, MD principal investigator
Centro Cardiologico Monzino, IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filterwire EZ™, MO.MA Ultra and Stent Roadsaver® in people with Carotid Stenosis, run by Centro Cardiologico Monzino at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piero Montorsi, MD (0039 0258002 ext. 576, piero.montorsi@ccfm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of microembolization signals (MES) detected with transcranial doppler (time frame: intraprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02915328, which also lists 1 linked publication.
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 27 Sep 2016.