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

NCT ID: NCT01274676

Last Updated: 2011-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Carotid Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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carotid stenting with MOMA

Group Type ACTIVE_COMPARATOR

carotid stenting with MOMA

Intervention Type DEVICE

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.

Carotid stenting with filter wire EZ

Group Type ACTIVE_COMPARATOR

Carotid stenting with filter wire EZ

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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MOMA device (INVATEC RONCADELLE, BRESCIA - ITALY) Filterwire EZ - Boston Scientific

Eligibility Criteria

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Inclusion Criteria

-patients with monolateral, significant, soft carotid stenosis

Exclusion Criteria

* patients with controlateral carotid occlusion
* patients with critic stenosis of the external carotid
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Cardiologico Monzino

OTHER

Sponsor Role lead

Responsible Party

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Centro Cardiologico Monzino, IRCCS

Principal Investigators

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Piero Montorsi, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Cardiologico Monzino, IRCCS

Locations

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Centro Cardiologico Monzino, IRCCS

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 21982309 (View on PubMed)

Other Identifiers

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S111/508

Identifier Type: -

Identifier Source: org_study_id

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