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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.

Primary Purpose

Carotid Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Filterwire EZ™
MO.MA Ultra
Stent Roadsaver®
Carotid Wallstent
Sponsored by
Centro Cardiologico Monzino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Cardiologico Monzino, IRCCSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Stent Roadsaver® +Filterwire EZ™

Stent Roadsaver® + MO.MA Ultra

Carotid Wallstent +MO.MA Ultra

Carotid Wallstent + Filterwire EZ™

Arm Description

The arm assess the efficacy of the combination of the stent Roadsaver® with the Filterwire EZ™ protection

The arm assess the efficacy of the combination of the stent Roadsaver® with the MO.MA Ultra protection

The arm assess the efficacy of the combination of the Carotid Wallstent with the MO.MA Ultra protection

The arm assess the efficacy of the combination of the Carotid Wallstent with the Filterwire EZ™ protection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical success
all strokes, major and minor strokes, myocardial infarction
6 month clinical follow up
all strokes, major and minor strokes, myocardial infarction
Doppler ultrasound assesment
stent patency and long term restenosis of target carotid artery and target vessel external carotid artery

Full Information

First Posted
September 20, 2016
Last Updated
September 23, 2016
Sponsor
Centro Cardiologico Monzino
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1. Study Identification

Unique Protocol Identification Number
NCT02915328
Brief 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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Cardiologico Monzino

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stent Roadsaver® +Filterwire EZ™
Arm Type
Experimental
Arm Description
The arm assess the efficacy of the combination of the stent Roadsaver® with the Filterwire EZ™ protection
Arm Title
Stent Roadsaver® + MO.MA Ultra
Arm Type
Experimental
Arm Description
The arm assess the efficacy of the combination of the stent Roadsaver® with the MO.MA Ultra protection
Arm Title
Carotid Wallstent +MO.MA Ultra
Arm Type
Experimental
Arm Description
The arm assess the efficacy of the combination of the Carotid Wallstent with the MO.MA Ultra protection
Arm Title
Carotid Wallstent + Filterwire EZ™
Arm Type
Experimental
Arm Description
The arm assess the efficacy of the combination of the Carotid Wallstent with the Filterwire EZ™ protection
Intervention Type
Device
Intervention Name(s)
Filterwire EZ™
Intervention Type
Device
Intervention Name(s)
MO.MA Ultra
Intervention Type
Device
Intervention Name(s)
Stent Roadsaver®
Intervention Type
Device
Intervention Name(s)
Carotid Wallstent
Primary Outcome Measure Information:
Title
number of microembolization signals (MES) detected with transcranial doppler
Description
different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device retrieval/deflation
Time Frame
intraprocedural
Secondary Outcome Measure Information:
Title
Clinical success
Description
all strokes, major and minor strokes, myocardial infarction
Time Frame
day 2 or day 3 and day 30 complication
Title
6 month clinical follow up
Description
all strokes, major and minor strokes, myocardial infarction
Time Frame
6 month
Title
Doppler ultrasound assesment
Description
stent patency and long term restenosis of target carotid artery and target vessel external carotid artery
Time Frame
day 2 or day 3, 1 month and 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piero Montorsi, MD
Phone
0039 0258002
Ext
576
Email
piero.montorsi@ccfm.it
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Galli, MD
Phone
0039 02 58002
Ext
533
Email
stefano.galli@ccfm.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piero Montorsi, MD
Organizational Affiliation
Centro Cardiologico Monzino, IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Cardiologico Monzino, IRCCS
City
Milan
State/Province
MI
ZIP/Postal Code
20138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piero Montorsi, MD
Phone
0038 0258002
Ext
576
First Name & Middle Initial & Last Name & Degree
Stefano Galli, MD
Phone
0038 0258002
Ext
533

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32007460
Citation
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.
Results Reference
derived

Learn more about this trial

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.

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