NCT01274676

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Centro Cardiologico Monzino · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2011-01-11
• Last updated: 2011-01-11

Locations

1 site across 1 country: Italy