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

NCT01274676 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2011-01-11

No results posted yet for this study

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.

Conditions

  • Carotid Stenosis

Interventions

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.

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.

Sponsors & Collaborators

  • Centro Cardiologico Monzino

    lead OTHER

Principal Investigators

  • Piero Montorsi, MD · Centro Cardiologico Monzino, IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01274676 on ClinicalTrials.gov