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

Primary Purpose

Carotid Stenosis

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

carotid stenting with MOMA

Carotid stenting with filter wire EZ

About this trial

This is an interventional prevention trial for Carotid Stenosis focused on measuring stenting, carotid plaque, stenosis, angioplasty

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-patients with monolateral, significant, soft carotid stenosis

Exclusion Criteria:

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

Sites / Locations

Centro Cardiologico Monzino, IRCCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

carotid stenting with MOMA

Carotid stenting with filter wire EZ

Arm Description

Outcomes

Primary Outcome Measures

number of Microembolization signals (MES) detected with transcranal doppler

Secondary Outcome Measures

Clinical success

Assesment of any clinical and neurological complication (death, any stroke, TIA; myocardial infarction).

Full Information

NCT ID

NCT01274676

First Posted

January 10, 2011

Last Updated

January 10, 2011

Sponsor

Centro Cardiologico Monzino

1. Study Identification

Unique Protocol Identification Number

NCT01274676

Brief Title

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

Acronym

MOMA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Centro Cardiologico Monzino

4. Oversight

Data Monitoring Committee

Yes

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. 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.

6. Conditions and Keywords

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

Carotid Stenosis

Keywords

stenting, carotid plaque, stenosis, angioplasty

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

carotid stenting with MOMA

Arm Type

Active Comparator

Arm Title

Carotid stenting with filter wire EZ

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

carotid stenting with MOMA

Other Intervention Name(s)

MOMA device (INVATEC RONCADELLE, BRESCIA - ITALY)

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Carotid stenting with filter wire EZ

Other Intervention Name(s)

Filterwire EZ - Boston Scientific

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Clinical success

Description

Assesment of any clinical and neurological complication (death, any stroke, TIA; myocardial infarction).

Time Frame

In hospital and 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: -patients with monolateral, significant, soft carotid stenosis Exclusion Criteria: patients with controlateral carotid occlusion patients with critic stenosis of the external carotid

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

ZIP/Postal Code

20138

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

21982309

Citation

Montorsi P, Caputi L, Galli S, Ciceri E, Ballerini G, Agrifoglio M, Ravagnani P, Trabattoni D, Pontone G, Fabbiocchi F, Loaldi A, Parati E, Andreini D, Veglia F, Bartorelli AL. Microembolization during carotid artery stenting in patients with high-risk, lipid-rich plaque. A randomized trial of proximal versus distal cerebral protection. J Am Coll Cardiol. 2011 Oct 11;58(16):1656-63. doi: 10.1016/j.jacc.2011.07.015.

Results Reference

derived

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

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