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.
September 23, 2016 updated by: Piero Montorsi, Centro Cardiologico Monzino
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
MI
-
Milan, MI, Italy, 20138
- Recruiting
- Centro Cardiologico Monzino, IRCCS
-
Contact:
- Piero Montorsi, MD
- Phone Number: 576 0038 0258002
-
Contact:
- Stefano Galli, MD
- Phone Number: 533 0038 0258002
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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
Exclusion Criteria:
- severe cerebral vasculopathy with cognitive impairment
- contraindication to double antiplatelet treatment
- controlateral carotid occlusion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Stent Roadsaver® +Filterwire EZ™
The arm assess the efficacy of the combination of the stent Roadsaver® with the Filterwire EZ™ protection
|
|
|
EXPERIMENTAL: Stent Roadsaver® + MO.MA Ultra
The arm assess the efficacy of the combination of the stent Roadsaver® with the MO.MA Ultra protection
|
|
|
EXPERIMENTAL: Carotid Wallstent +MO.MA Ultra
The arm assess the efficacy of the combination of the Carotid Wallstent with the MO.MA Ultra protection
|
|
|
EXPERIMENTAL: Carotid Wallstent + Filterwire EZ™
The arm assess the efficacy of the combination of the Carotid Wallstent with the Filterwire EZ™ protection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
intraprocedural
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical success
Time Frame: day 2 or day 3 and day 30 complication
|
all strokes, major and minor strokes, myocardial infarction
|
day 2 or day 3 and day 30 complication
|
|
6 month clinical follow up
Time Frame: 6 month
|
all strokes, major and minor strokes, myocardial infarction
|
6 month
|
|
Doppler ultrasound assesment
Time Frame: day 2 or day 3, 1 month and 6 month
|
stent patency and long term restenosis of target carotid artery and target vessel external carotid artery
|
day 2 or day 3, 1 month and 6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (ANTICIPATED)
April 1, 2018
Study Completion (ANTICIPATED)
April 1, 2018
Study Registration Dates
First Submitted
September 20, 2016
First Submitted That Met QC Criteria
September 23, 2016
First Posted (ESTIMATE)
September 27, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
September 27, 2016
Last Update Submitted That Met QC Criteria
September 23, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R323/15 - CCM334
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.