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

Carotid Stenosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274676
• Other study ID #: S111/508
• Status: Completed
• Phase: N/A
• First received: January 10, 2011
• Last updated: January 10, 2011
• Start date: February 2009
• Est. completion date: February 2010

Study information

• Verified date: September 2009
• Source: Centro Cardiologico Monzino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carotid Stenosis
• Constriction, Pathologic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Centro Cardiologico Monzino, IRCCS	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of Microembolization signals (MES) detected with transcranal doppler		6 different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device tetruieval/deflation	Yes
Secondary	Clinical success	Assesment of any clinical and neurological complication (death, any stroke, TIA; myocardial infarction).	In hospital and 30 days	Yes