Carotid Stenting in Patients With High Risk Carotid Stenosis ("Soft Plaque") (MOMA)

January 10, 2011 updated by: Centro Cardiologico Monzino

Randomized Trial of Proximal-versus Distal Cerebral Protection on Micro Embolization During Carotid Artery Stenting in Patients With High Risk Lipid Palque

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. Thanks to the systematic use of cerebral protection systems, these complications have reduced.A debate concerning which cerebral protective device should be more effective is still ongoing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

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
      • Milan, Italy, 20138
        • Centro Cardiologico Monzino, IRCCS

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-patients with monolateral, significant, soft carotid stenosis

Exclusion Criteria:

  • patients with controlateral carotid occlusion
  • patients with critic stenosis of the external carotid

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: carotid stenting with MOMA
Device: carotid stenting with MOMA
The MOMA system is an endovascular catheter for proximal protection during carotid stenting. The system allows a concomitant balloon occlusion of both external and common carotid arteries leading to blood flow reversal within the internal carotid artery.
Other Names:
  • MOMA device (INVATEC RONCADELLE, BRESCIA - ITALY)
Active Comparator: Carotid stenting with filter wire EZ
Device: Carotid stenting with filter wire EZ
The filter wire EZ a distal protection system that is placed in he distal internal carotid artery before carotid stenting. The filter should entrap almost all the debries that are generated during endovascular procedure. At the end of the procedure the filter is retrieved throught a dedicated retrieval catheter.
Other Names:
  • Filterwire EZ - Boston Scientific

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of Microembolization signals (MES) detected with transcranal doppler
Time Frame: 6 different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device tetruieval/deflation
6 different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device tetruieval/deflation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success
Time Frame: In hospital and 30 days
Assesment of any clinical and neurological complication (death, any stroke, TIA; myocardial infarction).
In hospital and 30 days

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

February 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

January 10, 2011

First Submitted That Met QC Criteria

January 10, 2011

First Posted (Estimate)

January 11, 2011

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S111/508

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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