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

  • Italy
    • 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
Device: Filterwire EZ™
Device: Stent Roadsaver®
EXPERIMENTAL: Stent Roadsaver® + MO.MA Ultra
The arm assess the efficacy of the combination of the stent Roadsaver® with the MO.MA Ultra protection
Device: Stent Roadsaver®
Device: MO.MA Ultra
EXPERIMENTAL: Carotid Wallstent +MO.MA Ultra
The arm assess the efficacy of the combination of the Carotid Wallstent with the MO.MA Ultra protection
Device: MO.MA Ultra
Device: Carotid Wallstent
EXPERIMENTAL: Carotid Wallstent + Filterwire EZ™
The arm assess the efficacy of the combination of the Carotid Wallstent with the Filterwire EZ™ protection
Device: Filterwire EZ™
Device: Carotid Wallstent

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

Centro Cardiologico Monzino

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.

General Publications

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.

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